Page 1
EN
FR
Compressor Nebulizer
NE-C803 (NE-C803-E)
Instruction Manual
IM-NE-C803-E-02-10/2014
DE
IT
ES
NL
RU
AR
8300641-7B
Page 2
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 ................................................................ 16
Changing the air filter................................................................................................ 16
Troubleshooting ........................................................................................................ 17
Technical data ........................................................................................................... 18
Guarantee ................................................................................................................. 21
Introduction
Thank you for purchasing the OMRON COMP AIR 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.
2
Medication Channel
Medication
Aerosol
Nozzle
Compressed Air
Page 3
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-C803 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
EN
Precautions for use
Warnings and cautions described in the instruction manual should be observed.
3
Page 4
Important safety instructions
Read all the information in the instruction manual and any other literature included in the box before
using the device.
Warning:
(Usage)
For type, dose, and regime of medication follow the instructions of your doctor or respiratory therapist.
If you feel anything unusual 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
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 in the parts.
Indicates a potentially hazardous situation which, if not avoided, could result in serious injury.
and wipe off the liquid with gauze or
4
Page 5
Caution:
Indicates a potentially hazardous situation which if not avoided, may result in minor or
moderate injury, or physical damage.
(Usage)
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.
(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.
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.
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 fire.
EN
5
Page 6
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 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.
6
Page 7
Know your unit
Compressor (Main Unit) x 1
Nebulizer Kit Holder
Nebulizer Kit x 1
Inhalation Top
Vaporizer Head
Medication Tank
Nozzle
Air Tube Connector
Air Tube Connector
Power Switch
Rear View
Mouthpiece x 1
Adult Mask (PVC) x 1
Power Connector
Air Filter Cover
*Air filter inside
Nosepiece x 1
Child Mask (PVC) x 1
EN
(PVC, 100cm) x 1
Spare Air Filters x 5Air Tube
AC Adapter x 1
Storage Bag x 1
Instruction Manual
7
Page 8
Optional Medical Accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
Product description Model
Nebulizer Kit & Mouthpiece Set NEB-NSET3-83E
Adult Mask (PVC)
Child Mask (PVC)
Adult Mask (SEBS)
Child Mask (SEBS) Set
Mouthpiece
Nosepiece
Air Tube (PVC, 100cm)
AC Adapter HHP-CF01
NEB-MSLP-E
NEB-MSMP-E
NEB-MSLS-E
NEB-MSSS-E
NEB-MP-E
NEB-NP-E
NEB-TP-82E
Other Optional/Replacement Parts
Product description Model
Air Filters x 5
NEB-AFR-30E
8
Page 9
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.
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.
EN
4.
Add the correct amount of prescribed
medication to the medication tank.
9
Page 10
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.
Small
Large
Arrow mark
Alignment
mark
10
Page 11
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.
The nebulizer kit can be fixed on the compressor.
Handle Handle
EN
11
Page 12
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.
Right angle
45°45°
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.
12
Compressor
Power plug
Page 13
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 T ube
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.
EN
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.
13
Page 14
Disinfecting
method
(See the next page)
Parts
Nosepiece
Mouthpiece
: applicable X: not applicable
o
(optional)
Nebulizer Kit
(optional)
Child Mask (SEBS)
Adult Mask (SEBS)
Adult Mask (PVC)
Air Tube
Child Mask (PVC)
(PVC, 100cm)
Air Filter
A
B
Materials
Alcohol
Disinfecting ethanol
Sodium hypochlorite
Milton*
(0.1%, 15min.)
Quaternary ammonium
Osvan*
(0.1%, 10min.)
Chlorhexidine
Hibitane*
(0.5%, 30min.)
Amphoteric
Surfactant
Tego 51*
(0.2%, 15min.)
Boiling
PP
PP
PP
Mask: SEBS
Band: Rubber
(Vaporizer Head: PC)
(non-latex)
Adapter: PP
Mask: PVC
(Phthalate free)
PVC
(non-latex)
Band: Rubber
Polyester
(Phthalate free)
oo o o o X X
oo o o o X X
oo o o o X X
oo o o o X X
oo o o o X X
oo o o X X X
14
Page 15
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.)
EN
15
Page 16
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.
16
Page 17
Troubleshooting
Check the following if the device should fail during operation.
Problem Cause Remedy
Nothing happens
when the power switch
is pressed.
No nebulization or
low nebulization rate,
when the power is on.
The compressor is
abnormally loud.
The compressor is
very hot.
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.
Is the AC adapter connected
correctly to a power outlet and
the compressor?
Is there medication in the
medication tank?
Is there too much/little
medication in the medication
tank?
Is the vaporizer head missing
or not assembled correctly?
Is the nebulizer kit assembled
correctly?
Is the nozzle blocked? Make sure that the nozzle is free of
Is the nebulizer kit tilted at a
sharp angle?
Is the air tube connected
correctly?
Is the air tube folded? Make sure that the air tube is not twisted or
Is the air tube blocked? Make sure that the air tube is free of
Is the air filter dirty? Replace the air filter with a new one.
Is the air filter cover attached
correctly?
Is the compressor being
covered?
Check that the AC adapter is connected to
a power outlet and the compressor. Unplug
then reinsert the plug if necessary.
Add the correct amount of medication to
the medication tank.
Attach the vaporizer head correctly.
Assemble the nebulizer kit correctly.
blockages.
Make sure that the nebulizer kit is not tilted
at an angle of more than 45 degrees.
Make sure that the air tube is correctly
connected to the compressor and nebulizer
kit.
bended.
blockages.
Attach the air filter cover correctly.
Do not cover the compressor during
operation.
EN
17
Page 18
Technical data
Product Description: Compressor Nebulizer
Model (-Code): NE-C803 (NE-C803-E)
Rating (AC adapter): 100 - 240V ~ 50/60Hz 0.12 - 0.065A
Rating (Compressor Nebulizer): 6V
Operating Temperature/Humidity: +10°C to +40°C / 30% to 85%RH
Storage and Transport
Temperature/Humidity/
Air Pressure:
Weight: Approx. 180g (compressor only)
Dimensions: Approx. 85 (W) × 43 (H) ×115 (D) mm (compressor only)
Contents: Compressor, Nebulizer Kit, Air Tube (PVC, 100cm),
Classifications: Class ll (Protection against electric shock),
0.7A
-20°C to +60°C / 10% to 95%RH / 700 - 1060hPa
Mouthpiece, Nosepiece, Adult Mask (PVC), Child Mask (PVC),
5 pcs Spare Air Filters, AC Adapter, Storage Bag, Instruction
Manual.
Type BF (Applied part)
IP21 (Ingress Protection)
= Class ll
equipment
= No operation
= Type BF
applied part
= Power on
Read the instruction
manual carefully
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.
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.
See website of OMRON HEALTHCARE EUROPE to update technical information.
URL: www.omron-healthcare.com
18
Page 19
Technical data for the OMRON NE-C803 Compressor with the Nebulizer kit:
Particle Size: **MMAD Approx. 3μm
MMAD = Mass Median Aerodynamic Diameter
Medication Tank Capacity: 10ml maximum
Appropriate Medication Quantities: 2ml minimum - 10ml maximum
Sound: *Less than 45dB
Nebulization Rate: *Approx. 0.30ml/min (by weight loss)
Aerosol Output: ** 0.37ml (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
0.1 1 10 100
Particle Size Dp (μm)
Mean
Individual
100
90
80
70
60
50
40
30
20
Cumulative Undersize %
10
0
* 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 EN 13544-1:2007+A1:2009.
Note:
Performance may vary with medication such as suspensions or high viscosity. See
medication supplier’s data sheet for further details.
19
EN
Page 20
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create a
potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to
prevent unsafe product situations, the EN60601-1-2:2007 standard has been implemented. This
standard defines the levels of immunity to electromagnetic interferences as well as maximum
levels of electromagnetic emissions for medical devices.
This medical device manufactured by OMRON HEALTHCARE conforms to this EN60601-12:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or
electromagnetic fields, near the medical device. This may result in incorrect operation of the unit
and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7 m. Verify correct operation of the device in
case the distance is shorter.
Further documentation in accordance with EN60601-1-2:2007 is available at OMRON
HEALTHCARE EUROPE at the address mentioned in this instruction manual.
Documentation is also available at www.omron-healthcare.com.
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 wastes for disposal.
(Waste Electrical & Electronic Equipment)
Correct Disposal of This Product
20
Page 21
Guarantee
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
a high level of comfort, provided that 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 covers only products purchased in Europe, Russia and other CIS
countries, Middle East and Africa.
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 unauthorised
persons.
c. Periodic check-ups and maintenance.
d. Failure or wear of accessories 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. If you have difficulties in
finding OMRON customer services, visit our website (www.omron-healthcare.com) for
contact information.
EN
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 / cashticket issued to the consumer by the retailer. OMRON reserves the
right to refuse the guarantee service if any unclear information has been given.
21
Page 22
Manufacturer
OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN
EU-representative
Production facility
Subsidiaries
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
No.28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II,
Binh Duong Industry-Services-Urban Complex, Hoa Phu Ward,
Thu Dau Mot City, Binh Duong Province, Vietnam
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK
www.omron-healthcare.co.uk
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY
www.omron-healthcare.de
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
www.omron-healthcare.fr
Made in Vietnam
22
Loading...