Omron DuoBaby NE-C301-AP User manual

NE-C28P-E_C_M05_151217.pdf
17B0236
Intended use
Medical Purpose
The intended purpose of this product is:
- To allow for nebulization treatment of respiratory tract disorders.
- To remove mucus form the nasal cavities to ease breathing.
Intended User
•Patient and/or caregiver under the direction of legally certified medical
experts, such as doctor, nurse and therapist or qualified medical experts
for home treatment.
•The user should also be capable of understanding general operation of
DuoBaby and the content of this instruction manual.
Intended Patients
Persons from the age of 1 month who suffer from upper airway conditions
(such as blocked nose, cold, allergies) and/or lower respiratory conditions
(such as asthma, bronchitis, bronchiolitis).
Environment
This product is intended for use in a 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 and environment.
Compressor (Main unit) 5 years
Nebulizer Kit 1 year
Mouthpiece 1 year
Air Tube 1 year
Air Filter 70 applications
Mask 1 year
Nasal Aspirator 1 year
Precautions for use
Warnings and cautions described in the instruction manual should be
observed.
Know your unit
Important safety instructions
Warning:
Indicates a potentially hazardous situation which, if not avoided,
could result in serious injury.
•A single-patient use is recommended.
•Do not use the device for other use than nebulization for human aerosol
therapy and for removing the mucus.
•Manufacturer will not be held responsible for inappropriate use of the
device.
•Use only original OMRON accessories as indicated in this instruction
manual.
•The correct functioning of the device may be affected by electromagnetic
interference caused by malfunctioning television sets, radios, etc. If this
occurs, move the source of interference away from the device or use a
different plug.
•For type, dose, and regime of medication follow the instructions of your
doctor or respiratory therapist. Before use check that you are using the
correct Inhalation top.
•If you feel or see 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 the reach of unsupervised infants and children.
The device may contain small pieces that can be swallowed.
•In view of their length, the power cord and air tube could constitute a
strangulation hazard.
•Do not store the air tube while there is moisture remaining inside.
•Always dispose of any remaining medication after use, and use fresh
medication each time.
•Do not use in anaesthetic or ventilator breathing circuits.
•Never block the ventilation slots. Never place the device where the
ventilation slots may be obstructed during operation.
•Never leave the nebulizer kit with medication near the ventilation slots,
this is to avoid medication entering the device.
•Store the parts in a clean location for avoiding 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.
•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.
•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 no wind the power cord around the compressor.
•Be sure to use the compressor at a place where the power plug is easily
accessible during treatment.
(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 daily disinfecting”
section.
•Clean and disinfect the nebulizer kit, baby mask, mouthpiece and nasal
aspirator 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.
•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.
Caution: Indicates a potentially hazardous situation which if not avoided,
may result in minor or moderate injury, or physical damage.
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 of either the nebulizer kit or aspirator or air tube are not
damaged or blocked.
- That the compressor operates normally.
•When using this device, there will be some noise and vibration caused
by the device. This is normal and does not indicate a malfunction.
•Do not use if the device or any parts are damaged. Replace damaged
parts.
•Do not subject the device or the parts to any strong shocks such as
dropping the device on the floor.
•Do not insert objects inside the compressor.
•Do not disassembly or attempt to repair the compressor or power cord.
•Do not leave the device or its parts in extreme hot or cold temperature,
or under direct sunlight.
Keep these instructions for future reference.
Optional Medical Accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
Product description Model
DuoBaby Nebulizer accessory set
(contents: nebulizer kit (includes two inhalation tops),
baby mask, adult mask, mouthpiece, 3 air filters, air
tube)
NEB2012
DuoBaby Aspirator accessory set
(contents: nasal aspirator, air tube) NEB7000
Other Optional/Replacement Parts
Product description Model
Air Filter set (contents: 3 pieces) 3AC408
Thank you for purchasing the Omron DuoBaby.
This product was developed in conjunction with respiratory therapists for the
successful treatment of asthma, chronic bronchitis, allergies, blocked nose,
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.
How the nasal aspirator kit works
The compressed air generated by the
compressor pump, passing through a
narrowing, thanks to the Venturi effect,
creates a vacuum which sucks the mucus
into the collection chamber.
Manufacturer 3A HEALTH CARE S.r.l.
Via Marziale Cerutti, 90F/G
25017 Lonato del Garda (BS)
Italy
Production
facility
3A HEALTH CARE S.r.l.
Via Marziale Cerutti, 90F/G
25017 Lonato del Garda (BS)
Italy
Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE LTD.
438A Alexandra Road, #05-05/08
Alexandra Technopark, Singapore 119967
www.omronhealthcare-ap.com
Made in Italy
Baffle
Aerosol
Medication
Aerosol
Nozzle
Medication
Compressed Air
Vacuum
Compressed Air
(Nebulizer: Usage)
•Provide close supervision when this device is used by, on, or near children,
invalids or persons who cannot express their consent.
•Make sure that the parts are attached or installed correctly.
•Make sure that the air filter is clean and correctly attached. If the air filter
has been used for more than 70 applications, replace it with a new one.
•Do not tilt the nebulizer kit at an angle of greater than 60 degrees in all
directions or shake it while in use.
•Do not use or store the device while the air tube is creased.
•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.
•This product should not be used on patients, who are unconscious,
sleeping, are drowsy or are not breathing spontaneously.
•Do not distort the vaporiser head, or jab the nozzle of the medication tank
with a pin or any sharp object.
•The compressor may become warm during operation, therefore do not
touch it other than turning it off after nebulizing.
•To avoid medication residue on the face, be sure to clean the patient’s face
after removing the mask.
(Nasal Aspirator: Usage)
•The nasal aspirator should be used exclusively for removing the nasal
mucus from a baby’s nose. It cannot be used for any other purpose.
•Do not obstruct the holes on the bottom of the nasal aspirator.
•If you notice rashes or redness appearing, inside or around the nose of the
baby during or after using the device or anything unusual during use, stop
using the device and consult a physician.
•Only use the original parts as included in the product.
•Do not attach the nasal aspirator to any other device.
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.
Important information regarding Electro Magnetic Compatibility (EMC)
DuoBaby (NE-C301-AP) 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
www.omronhealthcare-ap.com/emc-information.
Refer to the EMC information for DuoBaby (NE-C301-AP) on the website.
Compressor Nebulizer
with Nasal Aspirator
DuoBaby (NE-C301-AP)
Instruction Manual
IM-NE-C301-AP-EN-01-01/2019
3A4228 rev.00
Rear View
Power Cord
Accessories
Compartment
with Lid
Power Plug
Air Filter Cover
Including Air Filter
Ventilation Slots
Power Switch Air Tube
Connector
Nebulizer Kit and
Aspirator Holder
Compressor (Main Unit)
Baby Mask Mouthpiece Air Tube Instruction Manual
Nebulizer Kit
Inhalation Top x 2
Upper Airways Lower Airways
Vaporiser Head
Nozzle
Medication Tank
Air Tube Connector
Nasal Aspirator
1
2
Air Tube Connector
Finger
opening
Nozzle
O-ring
Collection
chamber
EN

Removing condensation from the air tube
If there is moisture remaining in the air tube, be sure to follow the procedure
below.
• Make sure that the air tube is connected to the air connector on the compressor.
• Remove the air tube from the nebulizer kit or the nasal aspirator.
• Turn on the compressor and pump air through the air tube to expel the moisture.
Changing the air filter
If the air filter has changed colour, or has been used for more than
70 applications, replace it with a new one. (see Other
Optional / Replacement Parts).
1. Remove the air filter cover as shown in figure.
2. Remove the old air filter with a sharp object,
such as a toothpick, and insert the new air filter.
3. Put the air filter cover back in place.
Notes:
• Use only OMRON air filters designed for this device. Do not operate without a filter.
• Do not attempt to wash or clean the filter. If the air filter becomes wet, replace it.
Damp air filters can cause blockages and may increase risk of infection.
• There is no front or back orientation for the air filters.
• Check that air filters are clean and free of dust before inserting them.
1. Make sure that the power switch is in the off ( ) position.
2. Assemble the nasal aspirator. Make sure that the O-ring is properly
attached. Refer to the drawing “Nasal Aspirator”.
3. Plug the power plug into a power outlet.
4. Connect the air tube to the nasal aspirator and
to the main unit, while twisting the air tube plugs
slightly, push them firmly.
5. Keep your baby in a comfortable position and
make sure that their head is lifted as shown on
the figure to the right.
6. Turn the power switch to the on ( ) position.
Place your index finger over the opening on the
nasal aspirator, as shown on the figure to the right
to begin aspiration.
Caution:
Before using the nasal aspirator, try it on the hand to
see if it sucks. When functioning properly, there must be
a slight suction from the nozzle. If air is exiting from the
nozzle, do not continue using the aspirator.
While using, the aspirator needs be in the upright position, with the finger opening
on top (see figure by above). This prevents the sucked mucus from entering parts
other than the collection chamber.
7. Place the nozzle at the entrance of one of the nostrils of the baby. (do not
insert inside the nostril). Use the aspirator for 3 seconds for 4 times per
nostril.
8. When treatment is completed, turn the power off and unplug the
compressor from the power outlet.
9.
Disconnect the aspirator from the air tube and disassemble it into 3 parts as
shown in “Know your unit”; clean or disinfect according to the section below.
Cleaning and daily disinfecting
Cleaning
Clean the parts after each use to remove residual medication or mucus.
This will prevent inefficient nebulization or aspiration and reduce the risk of
infection. Do not use a brush or pin to clean.
• Washable parts: Nebulizer kit, Baby Mask (PVC), Nasal Aspirator, Mouthpiece
Wash them 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 DuoBaby
nebulizer kit or nasal aspirator after some 100 to 120 treatments or after
about 20 boiling cycles.
•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, neutral detergent.
Air Filter
Do not wash or clean the air filter. Refer to “Changing the air filter” section.
Disinfecting
Always disinfect the parts after the last treatment of the day. 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 Nasal Aspirator Nebulizer Kit Baby Mask** Air Tube Air Filter
Materials
PP PP PP
Mask: PVC
(Phthalate
free) PVC
(Phthalate
free)
A
See
notes
below
Disinfecting ethanol o o o o X X
Sodium hypochlorite o o o o X X
Milton*
Quaternary ammonium o o o o X X
Osvan*
Chlorhexidine o o o o X X
Hibitane*
Amphoteric Surfactant o o o o X X
Tego*
BBoiling o o o XXX
* An example of commercially available disinfectant.
** Elastic band (non-latex). Do not disinfect.
Notes:
• Use a commercially available disinfectant. Follow the instructions provided by the
disinfectant manufacturer.
• Never clean with benzene, thinner or a flammable chemical.
• After having washed the Nebulizer Kit and/or Nasal Aspirator with the available
disinfectant, please rinse with clean warm water and dry thoroughly before using.
• Applicable 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.
Troubleshooting for: main unit, nebulizer kit and nasal
aspirator
Check the following if the device should fail before or during operation.
Problem Cause Remedy
Nothing happens
when the power
switch is turned.
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/
aspiration or low
nebulization, when
the power is on.
Is there sufficient medication
in the medication tank?
(only nebulizer kit)
Add the correct amount of
medication to the medication tank.
Is the vaporizer head missing
or not assembled correctly?
(only nebulizer kit)
Attach the vaporizer head
correctly.
Is the nebulizer kit or nasal
aspirator assembled correctly?
Assemble the nebulizer kit or
nasal aspirator correctly.
Is the nozzle for the nebulizer
kit or aspirator blocked?
Make sure that the nozzle is free
of blockages, do not pinch the
nozzle.
Is the nebulizer kit or nasal
aspirator tilted at a sharp
angle?
Make sure that the nebulizer kit
is tilted at an angle less than
60 degrees, or the aspirator is
upright.
Is the air tube connected
correctly?
Make sure that the air tube is
correctly connected to the
compressor and nebulizer kit or
nasal aspirator.
Is the air tube folded, blocked
or damaged?
Make sure that the air tube
does not contain kinks or is not
damaged or blocked.
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.
The compressor is
insufficiently ventilated.
Do not cover the compressor
during use.
Do not block the ventilation slots.
Do not use the device in an
environment with temperatures
higher than 40°C.
The compressor
suddenly stops
during use.
The thermal cut-out has
shut the device down due to
overheating
See note below.
Note:
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.
Technical data
Product Name: Compressor Nebulizer with Nasal
Aspirator
Model (code): DuoBaby (NE-C301-AP)
Rating: 230 V ~ 50 Hz
Power Consumption: 140 VA
Operating Temperature/
Humidity/Air Pressure:
+10°C to +40°C / 10% to 95%RH /
690 - 1060 hPa
Storage and Transport
Temperature/Humidity/
Air Pressure:
-20°C to +70°C / 5% to 95%RH /
690 - 1060 hPa
Weight: Approx. 1.7 kg (compressor only)
Dimensions: Approx. 170 (W) x 280 (D) x 105.5 (H) mm
Contents:
Compressor, Nebulizer Kit, Air tube,
Mouthpiece, Baby Mask, Nasal Aspirator,
Instruction Manual.
How to use nebulizer kit
1. Make sure that the power switch is in the off ( )
position.
2. Plug the power plug into a power outlet.
3. Remove the inhalation top from the medication tank.
1) Rotate the inhalation top anti-clockwise
2) Lift the inhalation top out from the medication tank.
4. Add the correct amount of prescribed
medication into the medication tank.
5. Verify the presence of the vaporiser
head inside the medication tank.
6. Choose the appropriate inhalation top by reading the
“User Guidance”.
To put the inhalation top back onto the medication tank.
1) Lower the inhalation top onto the medication tank.
2) Rotate the inhalation top clockwise.
7. Attach the Baby mask
or mouthpiece to the
nebulizer kit tightly.
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 60 degrees in all directions.
Medication may flow into the mouth or it may result in ineffective nebulization.
10. Turn the power switch to the on ( ) position. As the compressor starts,
nebulization begins and aerosol is generated. Inhale the medication.
Exhale through the nebulizer kit.
11. When treatment is completed, turn the power off and unplug the
compressor from the power outlet.
12. Clean and disinfect all (disassembled) parts according to the “Cleaning
and daily disinfecting” section.
How to use Nasal Aspirator
Dry and very thick mucus inside the nose may be dissolved by saline
solutions. After adding saline solution into each nostril of the baby’s nose
to help loosen nasal secretions, wait a few minutes and then remove the
mucus running out with a tissue. Only after removing the running mucus
outside the nostrils the nasal aspirator may be used.
1
2
Medication Tank
Vaporiser Head
1
2
Right angle
= Class ll
equipment
= Type BF
applied part =Power off
= Consult the
instructions for use
IP21= Ingress
protection =Power on
=
Alternating current
= Serial Number
=Batch code
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.
Nebulizer Kit
Appropriate Medication
Quantities:
1 ml minimum - 12 ml maximum
Sound: Noise level (at 1 m distance) 63 dB
Nebulizer
Upper Airways
Nebulizer
Lower Airways
Particle Size (MMAD*): Approx.9μm Approx.4μm
Nebulization Rate
(by weight loss):
Approx. 0.4 ml/min Approx. 0.2 ml/min
Aerosol Output
(3 ml, 1% NaF):
Approx. 0.54 ml Approx. 0.50 ml
Aerosol Output Rate
(1% NaF):
Approx. 0.16 ml/min Approx. 0.12 ml/min
*MMAD = Mass Median Aerodynamic Diameter
Result of cascade impactor measurements for particle size
Cumulative % particle mass of sodium fluoride undersize
Cumulative Undersize%
ParticleSizeDp(μm)
Inhalation Top 2 - Blue Color Lower Airways
Inhalation Top 1 - Green Color Upper Airways
Nasal Aspirator
Suction Pressure: Minimum -0.15 bar - Maximum -0.2 bar
Air Flow: Approx. 4 l/min
Maximum fill volume of
collection chamber: 7 ml
General Notes:
•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.
•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 drugs such as suspensions or high viscosity.
See drug supplier’s data sheet for further details.
•IP classification is degrees of protection provided by enclosures in
accordance with IEC 60529. The compressor is 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 SINGAPORE for complete up to
date information. URL: www.omronhealthcare-ap.com
User Guidance about the Nebulizer Kit
The DuoBaby nebulizer is a medical device that generates an aerosol with adjustable
characteristics to adapt to the patient’s respiratory pathology
Inhalation Top 2 – Blue Color for
Lower Airways: Treats conditions
such as: asthma, bronchitis,
bronchiolitis, bronchiectasis and
bronchopneumonia.
Particle size (MMAD) is
approximately4μm.
Inhalation Top 1 – Green Color for
Upper Airways: Treats conditions
such as: rhinitis, sinusitis, pharyngitis,
tonsillitis, and laryngitis.
Particle size (MMAD) is
approximately9μm.