Rhythm Healthcare AURA-NEB PCN843 User manual

ITEM# PCN843
AURA-NEB
COMPRESSOR NEBULIZER

2
Please ensure you have the following components
before using your Aura-Neb:
Compressor Body Angled Air Tubing Nebulizer Top, Cup
Mouthpiece and Pickup Funnel
Instruction Manual
(5) Air Filters

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INDEX
IMPORTANT SAFEGUARDS………………………………………………..4-6
Introduction………………………………………………….……………..…..7
Using Your Aura-Neb………………………………………………………….8
Cleaning……………………………………………………………………….12
Changing the Filter and maintenance………………………………………14
Troubleshooting……………………………………………………………….15
Warning and Cautions—Device Symbols………………………………….16
Electromagnetic Compatibility……………………………………………….18
Product Specifications………………………………………………………..26
Warranty……………………………………………………………………….28

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IMPORTANT SAFEGUARDS
Read and understand all instructions before use.
Improper care or use of the nebulizer may result in injury, damage to the
unit or ineffective treatment. Following these instructions will ensure the
nebulizer’s efficacy and long life. Nebulizer is non-sterile. Clean before
use. The device is suitable for both adult and pediatric as prescribed by a
physician.
When using an electrical product, especially when children are present,
basic safety precautions should always be followed.
DANGER: Urgent safety information for hazards that will cause serious injury or death.
WARNING: Important safety information for hazards that might cause serious injury.
CAUTION: Information for preventing damage to the product.
NOTE: Information to which you should pay special attention.
CAUTION Failure to read and observe all precautions could result in
personal injury or equipment damage.
DANGER To reduce the risk of electrocution
1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.

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IMPORTANT SAFEGUARDS
WARNING: To reduce the risk of burns, electrocution, fire, or injury
to persons:
1. The product should never be left unattended when plugged in.
2. Close supervision is necessary when this product is used by, on, or
near children or disabled individuals.
3. Use this product only for its intended use as described in this manual.
Do not use attachments that are not recommended by the
manufacturer.
4. Do NOT operate this product if:
a. It has a damaged power cord or plug.
b. It has been dropped or damaged.
c. It is not working properly.
d. It has been dropped into water.
5. Keep the power cord away from heated surfaces.
6. Never block the air openings of the product or place it on a soft
surface, such as bed or couch, where the air openings may be
blocked.
7. Never use while drowsy or sleeping.
8. Never drop or insert any object into any opening or hose.
9. Do NOT use outdoors. This product is for indoor/household use only.
10. Do NOT use this product with a DC to AC converter, or with any AC
voltage and/or frequency other than specified. SEE PRODUCT
SPECIFICATION on this manual.
11. Unplug the unit before filling the nebulizer.
12. Do NOT use this product in or near explosive environments, or where
aerosol (spray) products are being used.
13. Do NOT pump combustible liquids or vapors with the product or use in
or near an area where flammable or explosive liquids or vapors may
exist.
14. Do NOT operate this product in an oxygen enriched environment, i.e.,
oxygen tent or oxygen hood.
15. Use only in well ventilated areas. Do not expose and store the unit to
direct sunlight or at high temperature and humidity.

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IMPORTANT SAFEGUARDS
16. Do NOT operate unit in a backpack or carrying bag.
17. Care should be taken when this product is used near other electronic
equipment concerning the possible interference between them. They
may need to be moved apart.
18. Use caution when plugging in and unplugging device. Do not allow
jewelry or other metal items to contact plug.
19. Warning: This product contains small parts that may represent a
choking hazard.
20. Do NOT position the equipment so that it is difficult to operate.
21. To avoid strangulation and entanglement, keep power cord and air
tubes out of reach of young children.
22. The air filter shall not be serviced or maintained while the compressor
is in use.
23. Do NOT unplug the air tube during the treatment, otherwise may get
injured because of the effect of pressure.
24. Do NOT bend the air tubing of the unit where the air tube may be
obstructed.
25. No modification of this equipment is allowed.
26. The device does not need to be calibrated.
CLEANING WARNING
1. Clean all necessary parts before first use and after each treatment as
instructed in this manual. If the unit has not been used for an extended
period, all parts should be cleaned prior to use.
2. Disconnect the unit from the electrical outlet before cleaning.
3. Never immerse the unit in water to clean as it may damage the unit.
4. Do not use abrasive cleaners.
5. All accessories must be cleaned and not exchanged with other patient
before use to avoid cross contamination.
6. The mouthpiece should be replaced every thirty days.

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INTRODUCTION
Please read and understand this instruction manual completely before using your
unit, to ensure safe and effective use, as well as long life of the product.
Statement of Intended Use
The aerosol generator is for the production of compressed air to operate a
nebulizer for the production of medical aerosol for respiratory disorders. The
aerosol generator is used in conjunction with a pneumatic nebulizer which
nebulizes specific drugs for inhalation by a patient and requires the order of a
physician for medical use.
Compressor nebulizers are used to efficiently deliver medication in the form of a
mist to the lungs. Prescribed medicine is placed in the nebulizer and the
compressor blasts air through the liquid medication, converting it to an aerosol
mist which is then inhaled. This method of delivery is beneficial in the treatment
of asthma and other respiratory ailments, as the medicine is administered
directly to the bronchial passages of the lungs to provide quick and effective
relief. With proper use and care, your new nebulizer will provide you with many
years of safe, effective breathing therapy treatments.
CAUTION: Federal law restricts this device to be sold by or on the order of
a physician. Operate this unit only as instructed by your physician and/or
respiratory therapist.
Thoroughly read and understand the information contained in these instructions
on the use and care of this unit before operating. Save these instructions for future
reference. Any use of this product other than the purpose or which it is intended
shall void the warranty.

8
USING YOUR AURA-NEB
NOTE: Before the first use of the nebulizer or if the unit has not been used for
an extended period of time, it should be cleaned thoroughly as described in the
Cleaning section of this manual.
WARNING: Before connecting the power cord, make sure the I/O (ON/OFF)
switch is in the O (OFF) position. The plug is also served to disconnect the
device.
CAUTION: The Compressor is designed for intermittent use only. Do NOT
operate it continuously for more than 30 minutes for a single use without turning
it off and following a cooling period for least 30 minutes.
Note: the compressor pump motor has a thermal protector, which will turn the
power off before the unit overheats. If the thermal protector shuts the power off:
1. Switch the power switch to the OFF (O) position.
2. Unplug the power cord from the electrical outlet.
3. Ensure the air slots on the unit are not obstructed.
4. Wait 30 minutes for the motor to cool.
5. Restart the compressor.
6. If you are still experiencing issues, please contact your healthcare dealer for
assistance.

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USING YOUR AURA-NEB
The patient receiving treatment should be seated or slightly reclined in a
comfortable position as treatments take several minutes. Keep in mind that
the nebulizer cup must remain vertical during treatment.
1. Place the compressor unit on a flat, stable surface within operating range
of the patient and an electrical outlet. Ensure that the air vents on the side
of the unit housing are not blocked or obstructed and that the power is
off (O).
2. Plug the power cord into the electrical outlet.
3. Attach one end of the air tube to the tube connector at the back of the
unit. Turn on (I) the power briefly to ensure that the unit is functioning
properly and test that air is coming through the tubing, and then turn the
power off (O).
Disposable Nebulizer
This unit is intended for single patient use and should not be shared with
other people. This unit should be replaced every thirty days.

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USING YOUR AURA-NEB
4. Fill and assemble
the nebulizer.
Step 1: Make sure the pick-
up funnel is in place in the
bottom half of the nebulizer.
5. Step 2: Pour the
medication into the
nebulizer cup following
the physician prescribed
dosage, Fig 2.
6. Step 3: Replace the top
of the nebulizer and twist
to close; gently pull the
top to ensure the top is
secure, Fig 3.
7. Attach the selected
mouthpiece to the top of
the nebulizer, taking
care not to spill the
medication in the cup,
Fig 4.
8. Attach the nebulizer to
the air tubing, Fig 5.
Fig. 2
Fig. 4
Fig. 3
Fig. 5
NOTE: Treatment time varies depending on the type of medication and volume of
medication being used. It is important to complete the entire prescribed dose of medication
for maximum effectiveness. Consult with your prescribing physician or healthcare
professional for information on your specific medication therapy treatment plan.

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USING YOUR AURA-NEB
9. Position the mouthpiece at the patient’s mouth.
10. Turn the power switch to the on (I) position to
begin treatment. Inhale deeply and exhale
normally. Ensure the nebulizer is vertical during
treatment for proper nebulization of the
medication and to prevent spilling of the liquid.
11. If the vapor output becomes sporadic or if the
operation noise of the unit changes during use, turn
off (O) the unit and consult the
TROUBLESHOOTING section of this instruction
manual.
Mouthpiece position
12. When the treatment is complete, turn the unit off (O) and unplug it from
the outlet.
13. Disassemble, clean and store your nebulizer. Be certain that the
nebulizer pieces are completely dry before storage.
NOTE: IF THE VAPOR BEGINS TO SLOW AND THERE IS STILL MEDICATION IN
THE CUP, GENTLY TAP THE SIDE OF THE CUP TO SETTLE THE LIQUID AT THE
BOTTOM OF THE CUP FOR NEBULIZATION.

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CLEANING
NEBULIZER CLEANING
All parts of the nebulizer (except tubing) should be cleaned according to the
following instructions. Your physician and/or drug provider may specify a certain
cleaning procedure. If so, follow their recommendations.
WARNING: Clean nebulizer after each use. There is a risk of bacteria growth,
infection, illness from contamination due to a unsanitary nebulizer.
Cleaning:
1. Ensure that the power cord is
disconnected from the power outlet.
2. Disassemble nebulizer from
tubing and compressor. Do not
wash or submerge the air tubing.
3. Disassemble all parts of
nebulizer and rinse in running
water.
4. Clean nebulizer in warm soap
water. Rinse.
5. Allow the nebulizer and all parts to air
dry completely.
Fig. 1
Fig. 2

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CLEANING
COMPRESSOR CLEANING
1. With power switch in the “Off” position, unplug power cord from wall
outlet.
2. Wipe outside of the compressor cabinet with a clean damp cloth
every few days to keep dust-free.
CAUTION: Do NOT use any powdered cleaners or soap pads which may
damage the finish.
WARNING: Do not submerge in water; doing so will result in compressor
damage.

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CHANGING THE FILTER AND MAINTENANCE
Change the filter every 30 days or when filter turns gray or appears dirty.
CAUTION: Never operate the unit without a filter.
CAUTION: Do not substitute cotton or any other materials for the filters.
CAUTION: Do not attempt to clean the filters or reuse a filter.
To replace the filter, follow these steps:
1. Change the filter only when the unit is off, unplugged and completely cool.
2. Gently pull the filter cap out of the compressor.
3. Remove the filter from the filter cap.
4. Place a new filter in the filter cap.
5. Return the filter cap to its place, ensuring that it is firmly in place.
DANGER: Electrical shock hazard. Do not disassemble unit housing.
Pump maintenance must be performed by qualified service technician.

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TROUBLESHOOTING
The nebulizer produces no aerosol, or a small amount of aerosol.
•There may be too much or too little medicine in the nebulizer. The
amount of liquid should be between 2 ml and 8 ml.
•The hose connectors may be blocked and need to be cleaned
•The nebulizer may not be held upright. Always hold the nebulizer vertically
during use.
•The medication may not be suitable for nebulization. Check with your
doctor.
•The filter may need to be replaced.
•The air hose may be kinked.
Some medicine remains in the nebulizer at the end of my treatment.
This is normal. Once you hear a significant difference in the sound of the
nebulizer, you may stop inhaling.
What medications can be used in the nebulizer?
Only medications prescribed by your doctor should be used in the nebulizer.
Can I share the nebulizer with another person?
No. Each user must have their own nebulizer to ensure proper hygiene. The
compressor unit may be shared but not all the accessories.

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WARNING AND CAUTIONS—DEVICE SYMBOLS
These symbols may appear on your device, instructions or packaging and may
vary by make and model.
Symbol Meaning
Read This Manual—all included manuals should be read prior to first use
Warning—symbol indicates a warning, prohibition or mandatory action that
mitigates a risk that is not necessarily obvious to the device operator
Type BF Applied Parts—indicates that a part of this unit comes in contact with the
patient in order to carry out its intended function
Environment Protection—dispose of this product properly; consult with your local
recycling ordinances for proper recycling and disposal
IP21 Protection against solid objects and harmful effects due to ingress of water
Double Insulation—this unit is double-protected and thus corresponds to
protection class 2
OFF
ON

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WARNING AND CAUTIONS—DEVICE SYMBOLS
Symbol Meaning
Serial number
~Alternating current
Rx Only: Caution: Federal (U.S.) law restricts this device to sale by or on the
order of a physician.

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ELECTROMAGNETIC COMPATIBILITY
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment
Emissions test
Compliance
Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class [B]
The device is suitable for use in all
establishments Including domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies

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ELECTROMAGNETIC COMPATIBILITY
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment
Immunity Test
IEC 60601
Test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30 %
Electrical fast
transient/burst
IEC 61000-4-4
Power supply
lines：±2 kV
input/output
lines：±1 kV
Power supply
lines：±2 kV
Main power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
line(s) to
line(s)：±1 kV.
line(s) to
earth：±2 kV.
100 kHz
repetition
frequency
line(s) to
line(s) ：±1 kV.
100 kHz
repetition
frequency
Main power quality should
be that of a typical
commercial or hospital
environment.

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ELECTROMAGNETIC COMPATIBILITY
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
5% UT
(>95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25 cycles
<5% UT
(>95% dip in
UT)
for 5s
5% UT
(>95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in
UT)
for 5s
Main power quality should
be that of a typical
commercial or hospital
environment.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UTis the A.C. Main voltage prior to application of the test level.