Compressor Nebulizer
X105 Advanced
(NE-C105-EO)
Instruction Manual
IM-NE-C105-EO-01-11/2020
3A4460 rev.00
Issue Date/Date de publication/Ausgabedatum/
Data di pubblicazione/Fecha de publicación/
: 2021-01-07
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Table of Contents
Intended use ............................................................................3
How the nebulizer kit works .....................................................4
Nebulizer Kit with Advanced Valve Technology (AVT) ..............5
Know your unit .........................................................................6
Important safety instructions ....................................................7
How to use ...............................................................................8
Cleaning and daily disinfecting ...............................................12
Changing the air filter .............................................................13
Technical data ........................................................................14
Troubleshooting ......................................................................17
Warranty .................................................................................18
Optional Medical Accessories ................................................19
Other Optional/Replacement Parts ........................................19
Thank you for purchasing the OMRON X105 Advanced nebulizer.
This product was developed in conjunction with respiratory therapists
for the successful treatment of asthma, COPD (Chronic Obstructive
Pulmonary Disease), 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.
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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
or healthcare personnel or patient under the guidance of qualified
medical experts.
• The user should also be capable of understanding the general
operation of the X105 Advanced nebulizer and the content of this
instruction manual.
Intended Patients:
Persons who suffer from respiratory disorders and require inhalation of
medications.
Environment:
This product is intended for use in a medical facility, such as hospital,
clinic and doctor’s office, and in general household.
Durable period:
Durable periods are as follows, provided the product is used to nebulize
3 times a day for 10 minutes each time at room temperature (23°C).
Durable period may vary depending on usage environment.
Compressor (Main unit): 7.5 years
Power cord: 7.5 years
Nebulizer Kit / Mouthpiece /
Child Mask / Adult Mask /
Air Tube / Adapter: 1 year
Air Filter: 60 days
Frequent usage of the product may shorten the durable period.
4
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.
Baffle
Aerosol
Medication
Aerosol
Medication
Compressed Air
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Nebulizer Kit with Advanced Valve Technology (AVT)
The X105 Advanced nebulizer is equipped with a breath-enhanced valve
system which allows the maximum amount of medication to be inhaled
by the patient. It optimizes the flow of medication during inhalation and
reduces medication loss during exhalation.
By synchronizing the flow of aerosol with the breathing, the therapeutic
effect of the inhaled medication is optimized.
Note: Only using the mouthpiece enables the synchronized functioning of
the nebulizer!
Inhalation phase
During inhalation, the inhalation valve (A)
opens and air enters the nebulizer.
The air is mixed with the generated
aerosol (B) and inhaled through the
mouthpiece by the patient (C).
In this phase the exhalation valve (D)
remains closed preventing aerosol from
being wasted.
Exhalation phase
When exhaling through the mouthpiece,
the inhalation valve (A) of the nebulizer
closes, preventing aerosol to leave
the nebulizer. The aerosol generated
remains in the nebulizer and becomes
available for the next inhalation phase.
The exhaled air leaves the mouthpiece
through the exhalation valve (D).
B
A
D
C
A
D
6
Know your unit
Power Cord
Power Plug
Instruction manual
Carrying Bag
Spare Air Filters x 5
Support Adapter
for Child Mask
(PP)
Adult Mask
(PP+TPE)
including
elastic band
Mouthpiece
Cap
Inhalation
Valve
Exhalation
Valve
Air Tube
(PVC, 150 cm)
Air Tube Connector
Medication Tank
Vaporiser Head
Inhalation Top
Nebulizer Kit
Mouthpiece Set
Compressor
Socket
Rear View
Ventilation
Slots
Power Button +
Power Indicator
Nebulizer Kit
Holder
Air Tube
Connector
Air Filter Cover
Including air filter
Compressor (Main unit)
Child Mask
(PP+TPE)
including elastic
band
Nozzle
Power Cord
Power Plug
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Important safety instructions
Read the instructions carefully before use.
Warning:
1. Use the device only as inhalator for therapeutic purposes. Any
other use is improper and may be dangerous. The manufacturer is
not liable for improper uses.
2. Do not use in anaesthetic or ventilator breathing circuits.
3. Always disconnect the power plug after use.
4. Do not to cover the ventilation slots during use. The compressor
could get hot and there is a possible risk of a burn if touched.
5. The compressor and power plug are not waterproof. Do not spill
water or other liquids on these parts. If liquid does spill on these
parts, immediately unplug the power plug and wipe off the liquid.
6. Do not attempt to repair the device. See “Troubleshooting” section.
7. Keep the device out of reach of unsupervised infants and children.
The device may contain small pieces that can be swallowed.
8. Provide close supervision when this device is used by, on, or near
children or persons with limited capabilities.
9. For type, dose, and regime of medication follow the instructions of
your doctor or respiratory therapist.
10. This product should not be used on patients, who are unconscious
or are not breathing spontaneously.
11. After finishing the treatment remember to disconnect the air tube
from the nebulizer kit and from the compressor.
12. In view of their length, the power cord and air tube could constitute
a strangulation hazard.
13. Be sure to use the compressor at a place where the power plug is
easily accessible during treatment.
14. If you experience any allergic reactions or other difficulties during
use, stop using the device immediately and consult your doctor.
15. While using this device, make sure that no mobile phone or any
other electrical devices that emit electromagnetic fields is within
30 cm. This may result in degradation of performance of the
device.
16. Do not use oils, decoctions and tinctures from herbs for inhalation
in the compressor nebulizer.
8
How to use
1. Make sure that the power button is in OFF position. (The power
indicator is off.)
2. Insert the power cord into the compressor socket and then 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.
4. Verify that the vaporizer head is attached to the
inhalation top.
5. Add the correct amount of prescribed medication
into the medication tank. Be sure to follow the
instructions regarding the minimum and maximum
fill volumes (see Technical data). If the nebulizer
kit contains too little or too much medication; the
nebulization, and thus also the treatment, will be
greatly impaired.
2
1
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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.
Using the mouthpiece
7a. Assemble the mouthpiece.
Make sure that the valves are properly
attached.
Refer to this drawing.
7b. Attach the mouthpiece to the
nebulizer kit and press the cap
onto the inhalation top.
7c. Keep the mouthpiece in the
mouth during both inhalation
and exhalation in order to get
the maximal benefit by the valve
system.
Note: Infants or any patients who have particular
needs should use the mask instead of the
mouthpiece. When using a mask, make sure
the cap is removed from the inhalation top.
Caution:
In order to remove the mouthpiece from the nebulizer kit, it
is important to detach first the cap from the inhalation top
and then pull it out. Do not reverse this sequence!
1
2
1
2
10
Using the adult mask
7d. Attach the adult mask to the nebulizer kit.
Using the child mask and adapter
7e. Attach the child
mask to the
support adapter
and connect it to
the nebulizer kit.
8. Attach the air tube. While
twisting the air tube plug
slightly, push it firmly into the
air tube connector.
9. Hold the nebulizer kit as
indicated on the right.
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 ineffective nebulization.
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10. Power on the compressor by pressing the power button; the blue
power indicator is lit. As the compressor starts, nebulization begins,
and aerosol is generated. Gently inhale the medication. Exhale
through the mouthpiece.
11. When treatment is completed, press the power button again to power
off the device. Then unplug the compressor from the power outlet.
12
Cleaning and daily disinfecting
Observe the rules below when cleaning or disinfecting parts. Failure to
observe these rules may result in damage, inefficient nebulization or
infection.
Carefully wash your hands before cleaning and disinfecting the nebulizer
parts.
Clean and disinfect the Nebulizer Kit and its parts and accessories
(Masks, Mouthpiece and Adapter) before using them as follows:
- the first time after purchase (cleaning and disinfection)
- if the device has not been used for a long period of time (cleaning and
disinfection)
- if another person uses the same device (cleaning and disinfection)
- after each use (cleaning)
- after the last treatment of the day (cleaning and disinfection)
Ɣ Cleaning the Nebulizer Kit, Masks, Mouthpiece (including all parts)
and Adapter:
Fully disassemble the nebulizer kit. Remove the valves from the
mouthpiece. Wash the parts in warm water and mild, neutral detergent.
Rinse them thoroughly with clean hot tap water, gently tap to remove
excess water and allow to air dry in a clean place. It is advisable to
replace the Nebulizer Kit and Mouthpiece after some 100 to
120 treatments or after about 20 boiling cycles.
Ɣ Cleaning the Compressor:
Make sure that the power plug is unplugged from the power outlet.
Wipe clean with a soft cloth moistened with water or mild, neutral
detergent.
Ɣ Removing condensation from the Air Tube:
If moisture remains in the air tube, follow the procedure described below.
Make sure that the air tube is connected to the compressor. Disconnect
the air tube from the nebulizer kit. Turn on the compressor and dry the air
tube by passing air through it.
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Ɣ Disinfecting the Nebulizer Kit, Masks, Mouthpiece (including all
parts) and Adapter:
If the parts are heavily stained, replace them with new ones. The Nebulizer
Kit, Masks, Mouthpiece (including all parts) and Adapter can be disinfected
by using a chemical disinfectant such as ethanol, sodium hypochlorite
(Milton), following product instructions and rinsing off with clean warm
water. Leave to air-dry.
Note: Never clean with benzene, thinner or a flammable chemical. The
(non-latex) elastic bands cannot be disinfected. Remove them
when disinfecting the masks.
Ɣ Boiling:
The Nebulizer Kit, Mouthpiece (including all parts), Masks and Adapter
can also be disinfected by boiling between 15 to 20 minutes in plenty of
water. After boiling, carefully remove the parts, shake off excess water
and allow to air-dry in a clean environment.
Note: Do not boil the Air Tube.
Changing the air filter
If the air filter has changed color, or has been
used for more than 60 days, replace it with a
new one. To purchase the filters – see Other
Optional/Replacement Parts section.
Remove the air filter cover using a flat
screwdriver as shown in figure; remove the
filter and fit the new filter as shown.
Put the air filter cover back in place.
Note: Do not wash or clean the air filter. If the air
filter becomes wet, replace it.
Damp air filters can cause blockages
14
Technical data
Product Category: Aerosoltherapy Equipment
Product Description: Compressor Nebulizer
Model (code): X105 Advanced (NE-C105-EO)
Rating: 230V ~50Hz
Power Consumption: 140VA
Operating Mode: Continuous Use
Operating Temperature/
Humidity/Air Pressure:
+5°C to +40°C /
15% to 85%RH / 700 to 1060 hPa
Storage and Transport
Temperature/Humidity/
Air Pressure:
-20°C to +60°C / 5% to 95%RH /
500 to 1060 hPa
Classifications: Type BF (Applied part): Mouthpiece and
Masks
Class II (Protection against electric shock)
IP Classification: IP21
Weight of Compressor: Approx. 1.3 kg (compressor only)
Dimensions of
Compressor:
Approx. Ø 180 x 104 (H) mm
Contents: Compressor, Power Cord with EU Plug,
Power Cord with UK Plug, Nebulizer
Kit, Air Tube (150 cm), Mouthpiece Set,
Adapter, Adult Mask, Child Mask, Carrying
Bag, 5 pcs Spare Air Filters, Instruction
Manual
Appropriate Medication
Quantities:
2 ml minimum - 10 ml maximum
Residual volume of
medication:
Approx. 0.7 ml
Sound: Noise level
(at 1 m distance)
Approx. 55 dB
Particle Size (MMAD): $SSUR[ȝP
15
EN
Aerosol Output
(2 ml, 1% NaF):
Approx. 0.7 ml
Aerosol Output Rate
(2 ml, 1% NaF):
Approx. 0.12 ml/min
MMAD = Mass Median Aerodynamic Diameter
cumulative % mass of sodium fluoride undersize
Result of cascade impactor measurements for particle size
cumulative undersize %
SDUWLFOH'SȝP
0.10 1.00 10.00 100.00
100
80
60
40
20
0
____ Mean
........ Individual
16
Symbols description
Need for the user
to consult the
instructions for use
Humidity limitation
Applied part – Type BF
Degree of protection
against electric shock
(leakage current)
Atmospheric pressure
limitation
Class ll
Protection against
electric shock
Temperature
limitation
IP XX
Ingress protection
degree provided by
IEC 60529
Power ON/OFF
(push-push)
CE Marking Alternating current
LOT number Medical Device
Serial number Date of Manufacture
General Notes:
• IP classification is degrees of protection provided by enclosures in
accordance with IEC 60529. The compressor is protected against solid
foreign objects of 12 mm diameter and greater such as a finger, and
against vertically falling water drops which may cause issues during a
normal operation.
• Subject to technical modification without prior notice.
• The device may not work if the temperature and voltage conditions are
different to those defined in the specifications.
• Performance may vary with drugs such as suspensions or high
viscosity. See drug supplier’s data sheet for further details.
17
EN
Troubleshooting
In case of any of the below problems occur during use, first check that
no other electrical device is within 30 cm. If the problem persists, please
refer to the table below.
The device does not switch on
• Check that the power plug is properly fitted to the power outlet and the
power cord is connected to the socket of the compressor.
• Make sure the power button is in on position.
The device switches on but does not nebulize
• Make sure the vaporizer head is attached to the inhalation top of the
nebulizer kit.
• Make sure the air tube is not squashed or crooked.
• Check the air filter for blockage and dirt. Replace if necessary.
• Check that sufficient amount of medication has been put into the
nebulizer kit.
The device suddenly stops working during operation.
• The thermal cut-out has shut the device down for one of the following
reasons:
- the device was working in an environment with temperatures higher
than 40°C;
- the ventilation slots were covered.
Do not attempt to repair the device. Do not open and/or tamper with the
device. No parts of the device are user serviceable. Return the device to
an authorized OMRON retail outlet or distributor.
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.
18
Warranty
Thank you for buying an OMRON product. This product is constructed of
high quality materials and great care has been taken in its manufacturing.
It is designed to give you the highest level of comfort, provided it is
properly operated and maintained as described in the instruction manual.
This product is guaranteed by OMRON for a period of 3 years after the
date of purchase. The proper construction, workmanship and materials
of this product is guaranteed by OMRON. During this period of guarantee
OMRON will, without charge for labour or parts, repair or replace the
defect product or any defective parts. The guarantee does not cover any
of the following:
a. Transport costs and risks of transport.
b. Costs for repairs and/or defects resulting from repairs done by
unauthorized persons.
c. Periodic check-ups and maintenance.
d. Failure or wear of optional parts or other attachments other than the
main device itself, unless explicitly guaranteed above.
e. Costs arising due to non-acceptance of a claim (those will be charged
for).
f. Damages of any kind including personal caused accidentally or from
misuse.
Should guarantee service be required please apply to the dealer whom the
product was purchased from or an authorised OMRON distributor. For the
address refer to the product packaging / literature or to your specialised
retailer.
Repair or replacement under the guarantee does not give rise to any
extension or renewal of the guarantee period.
The guarantee will be granted only if the complete product is returned
together with the original invoice / cash ticket issued to the consumer by
the retailer. OMRON reserves the right to refuse the guarantee service if
any unclear information has been given.
19
EN
Optional Medical Accessories
Product Description Model
Nebulizer Kit NEB6026
Air Tube NEB6016
Mouthpiece Set
(Contents: Mouthpiece with cap,
Exhalation Valve, Inhalation Valve)
NEB6027
Child Mask (including elastic band) NEB6028
Adult Mask (including elastic band) NEB6029
Support Adapter for Child Mask NEB6030
Nasal shower NEB6014
Other Optional/Replacement Parts
Product Description Model
Power Cord with EU Plug 3AC459
Power Cord with UK Plug 3AC460
Air Filter Set (Contents: 5 pieces) 3AC458
Important information regarding Electro Magnetic Compatibility
(EMC)
This device manufactured by 3A HEALTH CARE S.r.l. conforms to
EN60601-1-2:2015 Electro Magnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available
at OMRON HEALTHCARE EUROPE at the address mentioned in this
instruction manual or at www.omron-healthcare.com.
DISPOSAL PROCEDURE (Dir. 2012/19/EU-WEEE)
This product is not to be treated as regular household waste but
must be returned to a collection point for recycling electric and
electronic devices. Further information is available from your
municipality, your municipality’s waste disposal services, or the
retailer where you purchased your product.
Manufacturer 3A HEALTH CARE S.r.l.
Via Marziale Cerutti, 90F/G
25017 Lonato del Garda (BS),
Italy
Distributor OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS
www.omron-healthcare.com
Subsidiaries Importer in
the United
Kingdom and
UK responsible
person
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes,
MK15 0DG, UK
www.omron-healthcare.com
OMRON MEDIZINTECHNIK
HANDELSGESELLSCHAFT mbH /
OMRON SANTÉ FRANCE SAS
www.omron-healthcare.com/distributors
Made in Italy
