Aura Medical PORTANEB NB40 User manual

OPERATION MANUAL
AURA
PORTANEB

INDICATION FOR USE
The Mesh Nebulizer model NB40 is an ultrasonic (vibrating mesh)
nebulizer system designed to aerosolize medications for inhalation by the
patient.
The device may be used by adult patients and pediatric patients at the
discretion of their physican at home, hospital &sub-acute care setting.
WARNING: U.S.Federal Law restricts this device to sale by or on the order
of a licensed physician. Do not use unless prescribed by a licensed
physician and with the prescribed medication only. Follow the physician’s
instructions for use at all times.
READ THIS MANUAL COMPLETELY AND CAREFULLY
BEFORE USING THIS PRODUCT
Keep this manual for future reference
06/17 Version: 3.0
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Do not place or store product where it can fall or be pulled into a bathtub,
sink, water, or other liquid. Risk of electric shock.
Do not use this product while bathing, showering, washing dishes, or close
to water sources of any kind. Risk of electric shock.
Do not place device in water or drop into water or other liquid. Do not allow
water to be sprayed onto the unit. The unit must be operated only when it is
completely dry. Risk of electric shock.
Do not reach for a product that has fallen into water or other liquid. If
possible, safely unplug immediately. Do not touch a wet supply cable or
plug. Do not touch the supply cable or plug with wet extremities.
Never touch the unit, including the AC adapter, with wet hands while it is
plugged in. This can cause an electric shock.
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SIGNS AND SYMBOLS
The following signs and symbols appear in this manual.
Read and understand this entire manual completely and carefully
before using this product. Follow all safety instructions and warnings to
avoid hazardous situation.
DANGER indicates a hazardous situation
which, if not avoided, will result in death or
serious injury.
WARNING indicates a hazardous situation
which, if not avoided, could result in death
or serious injury.
CAUTION indicates a hazardous situation
which, if not avoided, may result in minor
or moderate injury.
NOTICE addresses practices not related
to personal injury, such as product and/or
property damage.
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Before use, ensure that there is no visible damage to the unit or accessories.
Never operate the unit if it:
• has any damaged parts, e.g. damaged cord, plug or housing
• has been exposed to extreme humidity or to any liquids inside the housing
• has been dropped
• is not working properly
If the unit does not function correctly or if you notice any abnormalities, e.g.
an unusual noise or smell, stop using the unit immediately. Switch off and
unplug the unit immediately. When in doubt, do not use the unit and contact
the authorized distributor.
A product should never be left unattended when plugged in.
U.S. Federal Law restricts this device to be sold by or on the order of a
licensed physician. Do not use unless prescribed by a licensed physician
and with the prescribed medication only. Follow the physician’s instructions
for use at all times.
Using the unit is not a substitute for consultation with or treatment from a
physician. Whenever you have any pain, illness or discomfort, always contact
your physician first. If you have an emergency, call 911 immediately.
In the case of oversensitivity of the bronchial system, medicines containing
essential oils can sometimes cause acute bronchiospasm (a sudden,
cramp-like tightening of the bronchi accompanied by breathlessness). In
case of an emergency, call 911 immediately.
If you start feeling any discomfort, pain, drowsiness or other change in your
condition, stop using the unit immediately. For medical advice please
contact a licensed physician. If you have an emergency, call 911 immediately.
This device is not intended to be used by persons with restricted physical
(e.g. activity limitations, disabilities), sensory (e.g. insensitivity to pain) or
mental abilities (e.g. mental disorders) or persons lacking of the required
experience or knowledge for a safe operation of the device, unless closely
supervised by a person responsible for their safety. NEVER LEAVE THOSE
WHO REQUIRE CLOSE SUPERVISION UNATTENDED WITH THIS DEVICE.
This product contains small parts that may present a choking hazard to
children. Keep all small parts out of reach of children. The power cord also
presents a strangulation hazard. NEVER LEAVE CHILDREN OR THOSE WHO
REQUIRE CLOSE SUPERVISION UNATTENDED WITH THIS DEVICE.
Use the unit only on human being and for its intended purpose (aerosol
inhalation) and in the manner described in these instructions for use. Any
improper use can be dangerous!
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The following symbols are used on the packaging and on the nameplate
of the device and accessories.
Do not operate the unit in the presence of flammable gases, oxygen
andaerosol spray products. Non-compliance may result in e.g. fire, burns,
explosions, etc.
Single patient use only: For hygienic reasons, each user must use his own
accessories to avoid the risk of infections and communication of diseases.
During use, hold the unit away from the eyes as some nebulized medicines
may cause damage to the eyes.
Do not use this unit while driving a vehicle.
Never use while sleeping or feeling drowsy.
Do not administer treatment to a sleeping person, because not enough
medicine will reach the lungs.
Portable and mobile RF communication devices can disrupt electrical
medical equipment. Technical electromagnetic compatibility data is
available on request from the authorized distributor.
This unit is not intended for commercial or clinical use, but only for
individual, private household use! Do not allow others to use it.
Essential oils, cough medicines, solutions designed for gargling, and drops
for application to the skin or for use in steam baths are wholly unsuitable for
inhalation using a nebulizer. These substances are often highly viscous and
can impair the correct function of the device and hence affect the
effectiveness of its application in the long term.
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Protected against foreign objects equal to or greater then
12.5 mm in diameter and against drops of water falling at
up to 15° from vertical
Type BF applied
Follow instructions for use
Manufacturer
On/Off
Serial number
Device in protection class 2
Do not use outdoors
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CONTENTS
KEEP THIS MANUAL FOR FUTURE REFERENCE
2 GETTING ACQUAINTED
If the medicine tank is empty, do not attempt to operate the unit.•
1. Important safety notes
2. Getting acquainted
3. Important information on the device
4. Description of device and accessories
5. Initial use
6. Operation
7. Cleaning
8. Storage and care for the device
9. Disposal
10. Troubleshooting
11. FCC Statement
12. Technical specifications
13. Warranty and Service
If the instruction manual is damaged or if you no longer have the instruction
manual in your possession, please download one from our website:
www.aura-medical.com/support
The manufacturer shall not be held liable for damage or injuries caused by
improper or incorrect use.
Dear Valued Customer,
Thank you for purchasing our Aura NB40 Portable Nebulizer. To operate the
device properly and to achieve the best results, please read the instruction
manual thoroughly and keep it so that you can refer back to it if needed.
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AREA OF APPLICATION
3.1 ACCESSORIES
3.2 PROTECTING AGAINST LEAKS
3 IMPORTANT INFORMATION ON THE DEVICE
The NB40 Nebulizer must only be used with suitable NB40 accessories. The
use of other accessories may damage the device and can impair treatment
efficiency.
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Do not overfill the medicine container. The recommended filling amount is
between 2 ml. to 10 ml.
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The Aura Portable Nebulizer is an ultrasonic (vibrating mesh) nebulizer system
designed to aerosolize medications for inhalation by the patient. The device
may be used by both adult and pediatric patients and is suitable for use at
home.
The nebulization and inhalation of medication prescribed or recommended by
a doctor can prevent against diseases of the respiratory tract, treat the side
effects of these disorders and accelerate healing. For more information on
possible applications, consult your doctor or pharmacist. Medicines should
only be inhaled when instructed by a doctor. Inhalation should be performed in
a calm and relaxed atmosphere. Inhale slowly and deeply to enable the
medicine to reach the bronchi and deep into the lungs. Exhale normally.
When filling the medicine tank with medicine, ensure that you do not exceed
the maximum mark (10 ml). The recommended filling amount is between 2
and 10 ml. During use, you can tilt the device up to a maximum angle of 45° in
any direction, without impairing its nebulizing function or success of the
treatment. However, atomization only takes place if the medicine is in contact
with the mesh. If it is not, nebulization stops automatically. If this happens,
please try to hold the device as upright as possible.
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3.3 SHUTTING THE DEVICE OFF AFTER USE
OVERVIEW OF NEBULIZER
OVERVIEW OF NEBULIZER
4 DESCRIPTION OF DEVICE AND ACCESSORIES
When the medication cup is empty please shut off the device to avoid
damaging the mesh or internal elements.
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1. Nebulizer main unit
2. Medicine tank
3. Mesh transducer module
4. Electrode contact
5. Power On/ Off botton
6. Battery cover
7. Power DC jack socket
8. Led indicator for displaying
the operating status
9. Large Mask (Applied parts)
10. Small Mask (Applied parts)
11. Mask connector
12. Mouthpiece(Applied parts)
13. Alkaline AA battery X 2
14. AC adapter
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USING THE DEVICE FOR THE FIRST TIME
5.1 ASSEMBLING THE MEDICINE TANK
TO NEBULIZER MAIN UNIT:
5 Initial Use
Packaging materials are a deadly hazard for children and can cause
suffocation. Remove all packaging materials immediately and keep them
away from children at all times.
To reduce the risk of increased bacterial growth, infection, illness, injury
from contamination or other health risks, always follow all hygiene
instructions, see Section 7 Cleaning, when using this unit. Unplug the unit
before cleaning the unit.
Do not use the unit outside the specified ambient conditions. See Sections 8
Storage and Care for the Device and 12 Technical Specifications for details.
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Before first use, the nebulizer and the accessories should be cleaned.
Refer to Section 7 Cleaning for instructions.
Before use, ensure the device and accessories are at room temperature.
Remove the device from the packaging.
Connect the medicine tank to the nebulizer main unit. Make sure to connect
firmly so that you hear a “click” sound. Refer to Fig. 1.
Fig. 1
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5.2 OPERATING THE DEVICE WITH BATTERIES/
INSERTING BATTERIES:
Note:
To remove the medicine tank from nebulizer main unit, press the button (Refer
to Fig.2) and pull upward.
Swallowing batteries and/or battery fluid can be extremely dangerous. Keep
the batteries and unit out of the reach of children and disabled persons.
Should any person swallow a battery and/or battery fluid, call 911
immediately.
Should battery fluid leak and come into contact with your eyes or skin, rinse
with plenty of clean water immediately. Call 911 immediately.
Batteries should not be charged or reactivated by any other means.
Batteries should not be taken apart, thrown into the fire or short circuited.
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In case of a battery fluid leakage, do not touch the battery fluid. Avoid skin
contact (e.g. put on protective gloves) and clean the battery compartment
with a dry cloth.
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Always use the size and type of batteries indicated.
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Fig. 2
Button
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a. To open the battery cover on the underside of the device, apply light
pressure and pull the battery lid up.
b. Insert two batteries(type AA LR6)
c. Ensure that the poles of the batteries are touching their respective poles in
the device (Fig 3)
d. Press the battery cover lid down.
Note:
When changing batteries, ensure that the medicine container is completely
empty.
When the LEDs light up orange, you should replace the batteries.
You can operate the device for approx. 100 minutes with new alkaline
batteries.
This is sufficient for 5~8 uses of saline liquid
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Never use different types of batteries, battery brands or batteries with
different capacities.
Always replace all batteries at the same time.
Leaking batteries may damage the device. If you do not intend to use the
unit for a long period of time, remove the batteries from the battery
compartment before placing the device in storage.
When changing batteries, ensure that the medicine container is completely
empty, otherwise there is a risk of leaks.
Batteries can contain toxins that are harmful to the environment. Always
dispose of batteries in accordance with applicable local regulations. Do not
dispose of batteries with normal household waste.
Fig. 3
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Do not use any AC Adapter other than the one supplied with the unit.
When using the AC Adapter, take precaution of all warnings and safety
information in order to avoid hazardous situations.
Never touch the unit, including the AC Adapter with wet hands while it is
plugged in. This can cause an electric shock.
Do not pull the AC Adapter from the power outlet by the cord. Always grasp
the AC Adapter body and unplug it. Failure to do so could result in risk of
electric shock, short circuiting, or fire.
Do not pinch or bend the power cord or pull it over sharp objects. This can
cause an electric shock.
The unit and the AC Adapter must be protected and stored away from
sources of heat. (e.g. stoves, heating radiators).
The AC Adapter has a polarized plug (one blade is wider than the other). As
a safety feature, this plug will fit into a polarized outlet only one way. If the
plug does not fit fully into the outlet, reverse the plug. If it still does not fit,
contact a qualified electrician. Do not modify the plug in any way. Do not
attempt to manipulate with this safety feature.
Do not operate this device outdoors when using the AC Adapter. Risk of
electric shock.
Do not use extension cords, multi-sockets and/or voltage converters when
using the AC Adapter.
Always unplug this product immediately after use and make sure it is not
accessible to children.
A product should never be left unattended when plugged in.
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Before using the AC Adapter, always check the data plate on the bottom of
the NB40 Portable Nebulizer to ensure that the voltage and current
indicated on the unit correspond to the voltage and current available.
Lay the power cord in such a way that no one can trip over it. There is a
danger of injury due to e.g. stumbling, tripping, and falling down.
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Connect the AC adaptor only to the mains voltage listed on the type plate.
Insert the AC adaptor connector into the connecter socket on the unit, and
the AC adaptor fully into a suitable wall socket.
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6 OPERATION
Note:
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Ensure that there is a socket near to where the device will be used.
Use the mains cable in a way that no one can trip over it.
To disconnect the nebulizer from the mains after use, first switch off the
device and then remove the AC adaptor from the socket
The AC adaptor cannot be used for charging batteries.
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Always follow your physician’s instructions regarding the type of medicine to
be used, the dosage, frequency, and duration of inhalation. Any improper
use may cause hazardous situations.
Do not use medicine powder with liquid in this device. The Mesh transducer
module warranty excludes damage due to improper use causing powder
block on mesh hole.
• Before use, ensure that there is no visible damage to the unit or
accessories. Never operate the unit if it:
• has any damaged parts, e.g. damaged cord, plug or housing
• has been exposed to extreme humidity or to any liquids inside the housing
• has been dropped,
• is not working properly
Fig. 4
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6.1 Preparing the nebulizer
Note:
Before use, ensure the device and accessories are at room temperature.
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Do not use medicine with viscosity higher than 3 in this device. Mesh
transducer module warranty excludes damage due to incorrect or
inappropriate medicine viscosity used.
Apart from the prescribed medication, use only distilled water or a saline
solution with the unit. Other liquids may cause health problems. Always
consult your physician to determine what will be suitable for you.
Furthermore, other liquids may damage the mesh nebulizer and
accessories. When there is medicine inside the medicine tank, do not shake
nebulizer with force or put it through strong impact. Doing so may cause
liquid leakage into internal PCB and damage the device.
No liquid operation protection: NB40 is equipped with dual protection
technology to protect against ULTRASONIC transducer damage.
If there is no medicine in the medicine tank, the ultrasonic transducer will
stop operating.
If there is almost no medicine in the medicine tank, and residue of medicine
causes air bubbles, you can turn off the device manually.
If several different medicines are to be inhaled in succession, the medicine
tank and accessories must be cleaned after each use before using a
different medication. For more information, see Section 7 Cleaning.
Tilt operation range: Comparing with other similar nebulizers products which
can only operate very stable with vertical angle (90 degrees), the NB40 can
be used within 45 degree tilt angle. However, the nebulization will cease if
the tilt exceeds 45 degrees.
To reduce the risk of increased bacterial growth, infection, illness, injury
from contamination or other health risks always follow all hygiene
instructions, see Section 7 Cleaning, when using this unit. Unplug the unit
before cleaning the unit.
Check the Portable Nebulizer and all accessories before each use. Dirty,
damaged and/or worn parts may diminish or eliminate the effectiveness of
treatment. Replace damaged and/or worn parts. Dirty parts must be
cleaned following all hygiene instructions. See Section 7 Cleaning.
Do not use the unit outside the specified ambient conditions. See Sections 8
Storage and Care for the Device and 12 Technical Specifications for details.
•For hygienic reasons, it is imperative that the nebulizer and accompanying
accessories are cleaned after every use. If the treatment requires that
various different medicines be inhaled one after another, ensure that the
medicine tank is cleaned after every use. For details, see Section 7 Cleaning.
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6.2 Filling the nebulizer
6.3 Inhalation with the mouthpiece
a. Open the medicine tank by lifting the hook. (Refer to Fig.5, 6)
b. Fill the medication into the medicine tank. (Refer to Fig. 7)
c. Close the medicine tank by pressing the hook firmly and securely back to
place. (Refer to Fig. 8)
a. Connect mouthpiece to the medicine tank opening (Refer to Fig. 9)
b. Sit upright and hold the device as upright as possible, do not tilt the device
more than 45 degrees in any direction.
c. Enclose the mouthpiece completely with your lips.
d. Press On/ Off button. There will be blue LED light on On/ Off button.
Note:
At any time during a treatment, you can turn off the device by pressing
On/ Off button.
e. Breathe in slowly and deeply through your mouth and out through your
nose.
f. Once the medicine is nebulized completely, manually shut off the device.
Note:
Residue of medicine may remain inside the mouthpiece due to vapor
accumulation.
g. Disinfect and clean the device immediately after each use.
Note:
To prolong the mesh component life, allow at least 1 hour interval between
each treatment.
Fig. 5 Fig. 6 Fig. 7 Fig. 8
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6.4 Inhalation with the mask
a. Connect mask connector to the medicine tank opening, then connect mask
to the mask connector. (Refer to Fig. 10, 11)
b. Sit upright and hold the device as upright as possible, do not tilt the device
more than 45 degrees in any direction.
c. Put the mask connector between chamber and mask.
d. Press On/ Off button. The LED will light up blue when On.
Note:
At any time during treatment, you can turn off the device by pressing
On/ Off button.
e. Breathe slowly and deeply in and out through your nose.
f. Once the medicine is nebulized completely, shut off the device manually.
Note:
Residue of the medicine may remain inside the mask connector due to vapor
accumulation.
g. Disinfect and clean the device immediately after each use.
Note:
To prolong the mesh component life, allow at least 1 hour interval between
each treatment.
Fig. 9
Fig. 10 Fig. 11
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7 CLEANING
Note:
You can collect the residue of medicine inside mask tube and put it back to
medicine tank to vaporize again. (Refer to Fig.12)
• Before you clean the unit, always switch it off, unplug it and let it cool off.
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To reduce the risk of increased bacterial growth, infection, illness, injury
from contamination or other health risks, always follow all hygienic
instructions when using this unit. Unplug the unit before cleaning the unit.
For hygienic reasons, the medicine tank with mesh transducer module and
the accessories mouthpiece, mask connector, masks (not AC Adapter) must
be cleaned after each treatment and prior to initial operation.
Ensure that all parts are thoroughly dried after every cleaning. Residual
moisture or water droplets can result in an increased risk of bacterial growth
and therefore represent a risk for your health.
If several different medicines are to be inhaled in succession, the medicine
tank and accessories must be cleaned after each use before using a
different medication.
The medicine tank with the mesh transducer module and accessories must
not be mechanically cleaned with brushes or the like as this can cause
irreparable damage and may render the treatment ineffective.
For additional requirements regarding the necessary hygienic preparations
Fig. 12
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7.1 Cleaning and Drying
The nebulizer and accessories are intended for multiple uses.
Before you clean the device, always switch it off, unplug it and let it cool off.
7.1 Cleaning and Drying
The Aura Portable Nebulizer and the accessories used (mouthpiece, masks,
mask connector) must be cleaned with diluted soap water after each use.
Cleaning the medicine tank and mesh holes:
1. Open the cover of the medicine tank and discard the remaining medication.
2. Rinse the medicine tank with water.
3. Make a solution of 1 part white vinegar to 2 parts water. Pour into the
medicine tank and let it sit for 5 minutes.
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Ensure that no water penetrates inside the nebulizer main unit! Never
immerse the nebulizer main unit in water or any other liquid. Never hold the
nebulizer main unit under running water to clean it. Otherwise liquid can
enter the nebulizer main unit and cause damage.
While cleaning, ensure that that you do not touch the plastic mesh hole (in
the mesh transducer module) with your fingers or any other objects, as this
may destroy it. The mesh outlet (in the mesh transducer module) must not
be rinsed under running water, otherwise the mesh may be damaged.
Do not put the device or accessories in a dishwasher, washing machine or
tumble dryer.
Do not use any aggressive solvents, cleaning agents, detergents or any
other strong chemicals to clean the device.
(hand washing, handling of medicines or inhalation solutions) in high-risk
groups (e.g. cystic fibrosis patients), contact your physician.
When cleaning, ensure that all residues are removed. Never use any
substances that may be poisonous upon contact with the skin or mucous
membranes, or when swallowed or inhaled. When in doubt, contact your
physician for advice.
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7.1.2 Drying
7.2 Material resistance
Cleaning the accessories:
1. Clean the accessories (mouthpiece, masks, mask connector) with diluted
soap water and rinse.
2. Allow to air dry completely before packing away.
Cleaning the nebulizer main unit:
Clean the outside of the nebulizer main unit with a cotton cloth dampened with
water.
Do not allow water to enter the device.
Cleaning the nebulizer main unit:
Clean the outside of the nebulizer main unit with a cotton cloth dampened with
water.
Do not allow water to enter the device.
Place all the accessories on a dry, clean and absorbent surface and allow
them to dry completely.
Once all accessories are completely dry, store them in a dry and sealed
container.
As with all plastic components, frequent use and cleaning of the accessories
can lead to a certain amount of wear. Over time, this can alter the nebulization
properties and may eventually affect the efficiency of treatment. It is therefore
recommended that the mesh transducer module ( medicine tank) be replaced
at least once a year. In case of frequent use, replacement may be necessary
earlier.
Cleaning the 5 stainless steel poles:
Use a cotton swab dampened with water to clean the 5 stainless steel poles
contact on the nebulizer main unit (3 poles) and underneath the mesh
transducer module (2 poles).
4. Turn on the device and allow the solution to nebulize for 2 minutes.
5. Discard the vinegar solution. Add 4 cc’s of water and nebulize for 2 minutes.
6. Power off the device and discard remaining water.
7. Allow to air dry completely for 4-6 or overnight.
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8 STORAGE AND CARE FOR THE DEVICE
Note:
This cleaning procedure has been done and tested. The test conducted 30
treatments and cleaning cycles. Each treatment and cleaning cycle consisted
of placing an albuterol sample into the Portable Nebulizer, nebulizing it to the
end. After nebulizing, cleaning and drying the mesh transducer module,
medicine tank and accessories according to cleaning/ drying instructions
mentioned above.
Conclusion:
After the test was conducted, the nebulization performance of the nebulizer
showed no change in any parameters measured. It is concluded that the
cleaning procedure as described in the cleaning section above is effective and
safe. Visual inspection of the samples after exposure showed no degradation,
damage or cracks.
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Always unplug this product immediately after use and make sure it is not
accessible to children.
Do not open or disassemble the nebulizer. Risk of electric shock. All
disassembly and maintenance of the device must be performed by a
qualified service technician. If you need to have the unit repaired, please
contact the authorized distributor.
The unit and the AC Adapter must be protected and stored away from
sources of heat. (e.g. stoves, heating radiators)
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Avoid using the device in high electromagnetic environment.
Always keep the device out of reach of children.
• Protect the unit and the parts from strong impacts such as dropping the
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