B.Well PRO-110 User manual
Instruction for Use / Manual de Utilizare / Инструкция за експлоатация
EN RO BG
COMPRESSOR NEBULIZER
NEBULIZATOR СU COMPRESOR
МЕДИЦИНСКИ ИНХАЛАТОР
PRO-110
PRO-115
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COMPRESSOR NEBULIZER
PRO-110 / PRO-115
Table of contents
1. Introduction .................................................................................................................4
2. Intended Use...............................................................................................................4
3. Contraindications and use limitation...................................................................4
4. Precautions..................................................................................................................5
5. Components ................................................................................................................7
• Complete Set ...........................................................................................................8
• Nebulizer kit.............................................................................................................9
6. Preparation for use...................................................................................................9
• Nebulizer kit preparation for use ....................................................................10
• Air tube connection..............................................................................................10
7. Operating.....................................................................................................................11
8. Replacement of the Air filter................................................................................12
9. Cleaning, Maintenance and Storage..................................................................12
• Cleaning the device and accessories ..............................................................12
• Maintenance and Storage.................................................................................. 13
10. Disposal .....................................................................................................................13
11. Troubleshooting .......................................................................................................14
12. Specifications...........................................................................................................15
13. Applied standards...................................................................................................16
14. Warranty ...................................................................................................................16
15. Symbol Information ............................................................................................... 17
16. Latest revision .........................................................................................................21
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COMPRESSOR NEBULIZER
PRO-110 / PRO-115
Table of contents
1. Introduction .................................................................................................................4
2. Intended Use...............................................................................................................4
3. Contraindications and use limitation...................................................................4
4. Precautions..................................................................................................................5
5. Components ................................................................................................................7
• Complete Set ...........................................................................................................8
• Nebulizer kit.............................................................................................................9
6. Preparation for use...................................................................................................9
• Nebulizer kit preparation for use ....................................................................10
• Air tube connection..............................................................................................10
7. Operating.....................................................................................................................11
8. Replacement of the Air filter................................................................................12
9. Cleaning, Maintenance and Storage..................................................................12
• Cleaning the device and accessories ..............................................................12
• Maintenance and Storage.................................................................................. 13
10. Disposal .....................................................................................................................13
11. Troubleshooting .......................................................................................................14
12. Specifications...........................................................................................................15
13. Applied standards...................................................................................................16
14. Warranty ...................................................................................................................16
15. Symbol Information ............................................................................................... 17
16. Latest revision .........................................................................................................21
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Instruction for Use
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En
1. INTRODUCTION
Thank you for purchasing the Compressor Nebulizer B.Well PRO-110 / PRO-115.
The B.Well Nebulizer is a reliable device.
It creates a stream of air that travels through clear tube to the nebulizer. When air
enters the nebulizer, it will convert the prescribed medication into aerosol mist for easy
inhalation.
The B.Well company guarantees this device was made of high-quality materials and
meets national and international safety standards.
The Nebulizer is a medical device therefore it should be used under the supervision of a
licensed physician and/or a respiratory therapist.
Please, read this Instruction for Use carefully before use and follow the recommenda-
tions.
2. INTENDED USE
Your nebulizer is intended for use in treatment of asthma, COPD and other respiratory
ailments in which an aerosolized medication is required during therapy. Please consult
with your physician and/or pharmacist to determine if your prescription medication is
approved for use with this nebulizer. For type, dose, and regime of medication follow the
instructions of your doctor or respiratory therapist.
It is a compact medical device designed to efficiently deliver physician prescribed medi-
cation to the bronchial lung passages.
The particle size is less than 5 μm that allows treating lower respiratory tracts.
3. CONTRAINDICATIONS AND USE LIMITATION
The following is strictly forbidden to use as nebulizer therapy medicine:
•substances and solutions containing suspended particles (herbal infusions, suspen-
sions, extracts, etc.) Suspended particles are significantly larger than the particles of
respirable fraction. Using it in nebulizer can bring harm to health;
•oil-containing solutions (including ester oils). Oil particles form the finest films when
entering lower respiratory tract and this increases the risk of the so called “oil pneu-
monia”;
•anaesthetic mixture inflammable with air, oxygen or nitrogen protoxide;
•flavoring substances.
Use the device only as described in this Instruction for Use and therefore as an aerosol
therapy system, following the indications of your doctor.
MEDICAL DISCLAIMER:
This Instruction for Use and product are not meant to be a substitute for advice pro-
vided by your doctor or other medical professionals.
Don’t use the information contained herein or this product for diagnosing or treating a
health problem or prescribing any medication. If you have or suspect that you have a
medical problem, promptly consult your doctor.
*hereafter referred to as «nebulizer» and «inhaler» consider the same
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4. PRECAUTIONS
Read this Instruction for Use carefully before use. Keep it for future reference during the
life cycle of the device.
Use the device only as described in this Instruction for Use and therefore as an aerosol
therapy system, following the indications of your doctor. Any use different from the
intended one is to be considered improper and hence dangerous.
Do not operate the unit in presence of any anaesthetic mixture inflammable with oxy-
gen or nitrogen protoxide.
Device not suitable for use in anaesthesia or lung ventilation systems.
The manufacturer cannot be held liable for any damage caused by improper, incorrect
and/or unreasonable use, or if the equipment is connected to electrical installations
which do not comply with current safety regulations.
Rules of use the Nebulizer
For the B.Well Compressor Nebulizer PRO-110 and PRO-115 can be used all the medi-
cines allowed using with common aerosol therapy systems.
Use this device only with medicines prescribed by your doctor and according to his
instructions.
Make the treatment using only the accessory recommended by your doctor depending
on the pathology;
Use the nosepiece accessory only if expressly indicated by your doctor and paying at-
tention to NEVER introduce the bifurcations in the nose, but only bringing them as close
as possible.
Check in the medicine package leaflet for possible contraindications for use with com-
mon aerosol therapy systems.
Cautions:
•Closely follow the shelf-life instructions of the solutions which are allowed for use. Do
not use solutions with expired shelf-life.
•For greater hygienic safety, we recommend you to avoid using the same accessories
for more than one person.
•If you use the accessories for the first time, after long period of storage, and/or after
every use cleaning and disinfection of the accessories should be performed! Make sure
that all the components are properly disinfected and dried, and after that store it in
clean place.
•Components and device have to be cleaned according to the point 9. Cleaning, Mainte-
nance and Storage of current Instruction for Use.
•Always clean the nebulizer and its components from remaining drug and washing
substances. Never leave cleansing solution in chamber, mouthpiece or aerosol tube!
•Nebulizer and its components should not be dried in microwave oven, with hair dryer
and other household appliances.
•When using nebulizer do not close ventilation holes of the device. Do not cover the
nebulizer with a blanket, towel, etc. when using it. Never put the device in a place with
the possibility of blocked entry of air to these holes.
•Some parts of the unit are so small that they may be swallowed by children; keep the
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equipment out from children’s reach. The use of this device by children and disabled
requires always the close supervision by an adult with full mental faculties. To avoid
strangulation and entanglement, keep cable and air tubes out of reach of children.
•Do not expose to harmful vapors or volatile substances.
•Do not pour more than 8 ml of drug solution into the container.
•Do not incline the nebulizer at more than 45 degrees when using, do not shake it.
•Do not over bend the air tube while both storing and using.
•Do not drop the device and expose to damage.
•Do not block the cap of air filter.
•The device is approved only for human use. Use it only for the purpose intended.
Electric shock hazard
•Use only original accessories and components;
•Never wet the device, it is not protected against water penetration;
•Never touch the unit with wet or moist hands;
•Do not leave the unit exposed to the weather elements;
•Before performing any maintenance or cleaning operation, turn off the device and
disconnect the plug from the main supply.
•Do not leave the unit plugged in when not in use; unplug the device from the wall
socket when it is not operated.
•Do not disconnect the Nebulizer when the device is on.
•Place the unit on a stable and horizontal surface during its operation;
•Never submerge the unit in water;
•The power supply cord should always be fully unwound in order to prevent dangerous
overheating. The power cord of this device cannot be replaced by the user. In case of a
power cord damage, address to a technical service center authorized by the manufac-
turer for its replacement.
•Do not allow contact of the power cord with hot surfaces.
•Do not pull the power cord or the device itself to unplug it from the power socket;
•For repair operations address only to a technical service center authorized by the
manufacturer and require the use of original spare parts. The non-observation of the
above mentioned indications can compromise the device safety.
The correct functioning of the equipment can be affected by electromagnetic interfer-
ences which exceed the limits indicated by the European standards in force. In case this
device interferes with other electrical devices, move it and plug it to a different power
socket.
In case of failure and/or malfunction, read the “11. Troubleshooting” section. Do not
handle or open the compressor housing.
Before plugging in the device, make sure that the electrical rating, shown on the rating
plate on the bottom of the unit, corresponds to the mains rating.
In case the power plug provided with the device does not fit your wall socket, address to
qualified personnel for the problem solving.
In general, the use of extension cables is not recommended. If their use is indispensable,
it is necessary to use types complying with safety regulations.
The installation must be carried out according to the instructions of the manufacturer.
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An improper installation can cause damage to persons, animals or things, for which the
manufacturer cannot be held responsible.
If you decide not to use the device any longer, it is recommended to dispose of it accord-
ing to the current regulations.
Do not position the equipment so that it is difficult to operate the disconnection device.
5. COMPONENTS
1 Compressor housing
2 ON/OFF switch
3 Air outlet
4 Filter case
5 Nebulizer holder
6 Air-vent openings
2
6
3 15
4
4
6
5
2 3
1
1
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Complete set
Components Complete set
PRO-110 Complete set
PRO-115
1. Compressor nebulizer 1 pcs. 1 pcs.
2. Nebulizer kit Basic 1 pcs. 1 pcs.
3. Air tube 1 pcs. 1 pcs.
4. Mouthpiece 1 pcs. 1 pcs.
5. Nosepiece 1 pcs. 1 pcs.
6. Adult mask 1 pcs. 1 pcs.
7. Child mask 1 pcs. 1 pcs.
8. Infant mask
-
1 pcs.
9. Spare air filter 5 pcs. 5 pcs.
10. Accessories bag 1 pcs. 1 pcs.
Инструкция по эксплуатации / Instruction for Use / Пайдалану нұсқаулығы
RU EN KZ
PRO-110
PRO-115
Ингалятор медицинский
11. Instruction for Use 1 pcs. 1 pcs.
12. Stickers
-
2 pcs.
Nebulizer kit Basic
Thank for the Venturi effect, the air 2
is taken from the environment through
top opening 1 in addition to the air
supplied by the compressor 3 , thereby
increasing nebulization speed and decreasing
treatment time 4 .
6. PREPARATION FOR USE
The device must be checked before each use, in order to detect possible functioning
anomalies and/or damages due to transport and/or storage.
During inhalation, sit upright and relaxed at a table and not in an armchair, in order to
avoid compressing your respiratory airways and impairing the treatment effectiveness.
The accessories must be used only with a single patient, it is not recommended to use
them with several patients.
•Wash your hands carefully before using the device.
•After unpacking the device, check it for visible damages or defects; pay particular
attention to cracks in the plastic housing, which may expose electrical components.
Check for accessories integrity.
•Wash and disinfect the Nebulizer, mouthpiece, nosepiece, mask (if they are used for
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9. Spare air filter 5 pcs. 5 pcs.
10. Accessories bag 1 pcs. 1 pcs.
Инструкция по эксплуатации / Instruction for Use / Пайдалану нұсқаулығы
RU EN KZ
PRO-110
PRO-115
Ингалятор медицинский
11. Instruction for Use 1 pcs. 1 pcs.
12. Stickers
-
2 pcs.
Nebulizer kit Basic
Thank for the Venturi effect, the air 2
is taken from the environment through
top opening 1 in addition to the air
supplied by the compressor 3 , thereby
increasing nebulization speed and decreasing
treatment time 4 .
Bottom
(medication cup)
Diffuser
Nebulizer
top
3
1
4
2
6. PREPARATION FOR USE
The device must be checked before each use, in order to detect possible functioning
anomalies and/or damages due to transport and/or storage.
During inhalation, sit upright and relaxed at a table and not in an armchair, in order to
avoid compressing your respiratory airways and impairing the treatment effectiveness.
The accessories must be used only with a single patient, it is not recommended to use
them with several patients.
•Wash your hands carefully before using the device.
•After unpacking the device, check it for visible damages or defects; pay particular
attention to cracks in the plastic housing, which may expose electrical components.
Check for accessories integrity.
•Wash and disinfect the Nebulizer, mouthpiece, nosepiece, mask (if they are used for
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the first time after long period of storage and/or if they are used by several persons).
Before using the device, proceed with the cleaning operations as described in the «9.
Cleaning, maintenance and storage» section.
•Place the device on a stable and horizontal surface so that you can easily reach the
Nebulizer, Accessories and ON/OFF Switch when you do the inhalation.
Before using of the device make sure that:
•all the components are properly assembled;
•air filter is inside of the filter cap;
•air filter is clean (if air filter has changed the color or has been used for a long period of
time, replace it with a new one).
Nebulizer kit preparation for use
1. Open the nebulizer by turning counterclockwise the top
2. Make sure that the medicine conduction cone is properly fitted on the air conduction
cone inside the nebulizer
3. Put the prescribed quantity of medicine into the nebulizer
4. Close the nebulizer by turning clockwise the two parts, paying attention that they are
thoroughly sealed
NOTICE! Capacity of container for drugs is equal to 2-8 ml. There is a scale on the
container for drugs. It serves for rough estimate of drug solution capacity.
Air tube connection
Connect one end of the air tube to the nebulizer and
the other end to the air outlet on the device.
Make sure that air tube is properly attached in order
to avoid air leakage.
WARNING! Hold the nebulizer strictly vertically,
do not spill the drug when attaching the air tube.
Insert the mask or mouthpiece directly onto the nebulizer
•Make sure the switch ON/OFF switch into the «О» position.
•Plug the device into the wall socket, making sure that
the main supply corresponds to the electrical rating
of the device.
•Press the power-switch to the position ON «I».
7. OPERATING
Hold the nebulizer strictly vertically.
WARNING! Do not incline the nebulizer at more than 45 degrees.
If the angle is greater than 45 degree, the drug can flow out to your mouth.
To start the treatment, set the switch into the «I» position. The compressor will start
working and a nebulizing will begin
Do the treatment in accordance with your doctor’s instructions.
Inhale the aerosol solution using the prescribed accessory.
WARNING! The temperature of inhaled aerosol depends on the temperature of the
ambient atmosphere and the temperature of the drug solution. If the solution was
stored in refrigerator for a long period of time, it is recommended to raise the
temperature to 16-20С°.
Use of mouthpiece:
Take the mouthpiece to your mouth and breathe smoothly during the inhalation.
Using of mouthpiece is recommended in treatment of lower respiratory tract in grown-
ups and children above 5 years old.
Use of masks:
Put on a mask in the way that it will close your nose and mouth, and conduct inhalation
of the drug. Inhale and exhale through the mask.
Using of mask is recommended in treatment of upper respiratory tract. It allows for
irrigation of the whole nasal and pharynx cavities, and also larynx and trachea.
Child mask is recommended for use for children aged from 1 to 5 years old Infant mask
for children under 1 year old.
When the treatment has been completed, switch the unit off by setting the switch into
the «O» position and disconnect the plug from the wall socket.
Wash the nebulizer and its accessories as described in the section «9. Cleaning, Mainte-
nance and Storage».
Condensate can form in the air tube. In this case detach the air tube from the nebulizer,
turn on the compressor and dry the air tube till the elimination of all the liquid.
WARNING! Do not store the air tube if there is condensate or liquid inside. It can
lead to bacterial infection.
Switch off the device from the socket.
Rinse your mouth with boiled water of the ambient temperature after the procedure. If
you used mask – rinse your eyes and face with water.
WARNING! The device can work for 30 min without a pause, than you should let
the device to cool down for 30 min.
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7. OPERATING
Hold the nebulizer strictly vertically.
WARNING! Do not incline the nebulizer at more than 45 degrees.
If the angle is greater than 45 degree, the drug can flow out to your mouth.
To start the treatment, set the switch into the «I» position. The compressor will start
working and a nebulizing will begin
Do the treatment in accordance with your doctor’s instructions.
Inhale the aerosol solution using the prescribed accessory.
WARNING! The temperature of inhaled aerosol depends on the temperature of the
ambient atmosphere and the temperature of the drug solution. If the solution was
stored in refrigerator for a long period of time, it is recommended to raise the
temperature to 16-20С°.
Use of mouthpiece:
Take the mouthpiece to your mouth and breathe smoothly during the inhalation.
Using of mouthpiece is recommended in treatment of lower respiratory tract in grown-
ups and children above 5 years old.
Use of masks:
Put on a mask in the way that it will close your nose and mouth, and conduct inhalation
of the drug. Inhale and exhale through the mask.
Using of mask is recommended in treatment of upper respiratory tract. It allows for
irrigation of the whole nasal and pharynx cavities, and also larynx and trachea.
Child mask is recommended for use for children aged from 1 to 5 years old Infant mask
for children under 1 year old.
When the treatment has been completed, switch the unit off by setting the switch into
the «O» position and disconnect the plug from the wall socket.
Wash the nebulizer and its accessories as described in the section «9. Cleaning, Mainte-
nance and Storage».
Condensate can form in the air tube. In this case detach the air tube from the nebulizer,
turn on the compressor and dry the air tube till the elimination of all the liquid.
WARNING! Do not store the air tube if there is condensate or liquid inside. It can
lead to bacterial infection.
Switch off the device from the socket.
Rinse your mouth with boiled water of the ambient temperature after the procedure. If
you used mask – rinse your eyes and face with water.
WARNING! The device can work for 30 min without a pause, than you should let
the device to cool down for 30 min.
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8. REPLACEMENT OF THE AIR FILTER
The Air filter must be replaced in case of damage or severe contamination.
In normal usage conditions, the air filter must be replaced approximately after 500 work-
ing hours or after each year.
It is recommended periodically checking the air filter (10 – 12 treatments) and, if the filter
shows a grey or brown color or is wet, replace it.
1. Turn the air filter cover counterclockwise (only for PRO-115)
2. Extract the air filter bladder from the device by pulling it up
3. Extract the filter and replace it with a new one (for example with the help of tweezers)
4. Set the air filter bladder on its place
5. Turn the cover clockwise to fix it (only for the PRO-115)
WARNING! The use of dirty filter or filter made of another material, for example,
cotton, may lead to device damage. Use original filters only.
•Do not use the device without filter.
•Do not try to clean the filter for reusing it. If the filter is wet replace it.
•The air filter shall not be serviced or maintained while in use with a patient.
•To avoid the air filter cover obstruction clean it regularly.
WARNING! Air filters cannot be cleaned or washed.
9. CLEANING, MAINTENANCE AND STORAGE
Cleaning the device and the accessories
The cleaning of the device must be carried out by using a soft and dry cloth and non-
abrasive cleansers.
ATTENTION! During cleaning operations, make sure the internal parts of the unit
are not in contact with liquids and that the power plug is disconnected.
Follow carefully the cleaning and disinfection instructions of the accessories as they are
very important for the device performances and the therapy success.
ATTENTION! Before first using of the device and after each treatment it is
necessary to clean all the accessories according to the following instructions:
•Disassemble the nebulizer by turning counterclockwise the top and remove the medi-
cine conduction cone.
•Wash the components of the disassembled nebulizer, the mouthpiece and nosepiece
by using tap water; dip in boiling water for 5 minutes.
•Reassemble the nebulizer components and connect it to the air-outlet, switch the
device on and let it work for 10-15 minutes or put on the clean paper towel for drying
on the air.
•The masks and air tube must be washed with warm water. Does neither boil nor
autoclave the air tube and masks!
Sterilization:
•Use cold disinfecting liquids following the instructions of the sterilization liquids’
manufacturer.
•Wash your hands and take the components out from disinfection solution, wash the
components in warm running water, lay the components on paper towel and dry.
•Do not wipe disinfected parts of the device with a towel; do not use hair dyer, micro-
wave oven or other household appliances for drying. The outer surface of wet parts
can be wiped with a clean dry cloth.
Caution: In order to avoid spread of infections it is recommended to conduct disinfection
of device components before first and after every use. Use for treatment only the drugs
prescribed by your attending doctor and strictly follow his/her indications.
Opening of the device is prohibited. Repair of the device should be conducted only in
technical service centers recommended by B.Well company.
Note: the nebulizer need to be replaced after 6-12 months depending on the usage.
The nebulizer must be replaced after a long period of inactivity, in case it shows
deformations or breakings, or when the nebulizer nozzle (diffuser) is obstructed by dry
medicine, dust, etc.
Use original nebulizers only.
Maintenance and storage
If you want your device to serve you for years, follow the following indications:
•do not store the device at extremely high or low temperatures, high humidity or under
direct sunlight;
•do not bend or wrap the air tube.
Operation and storage conditions – please see «12. Specification» section
Utilization of the device and any of its components should be performed in accordance
with the local regulations.
10. DISPOSAL
The unit must be disposed in accordance with current standards separately from
domestic wastes.
For disposal it is necessary to contact special organizations licensed to make utilization.
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8. REPLACEMENT OF THE AIR FILTER
The Air filter must be replaced in case of damage or severe contamination.
In normal usage conditions, the air filter must be replaced approximately after 500 work-
ing hours or after each year.
It is recommended periodically checking the air filter (10 – 12 treatments) and, if the filter
shows a grey or brown color or is wet, replace it.
1. Turn the air filter cover counterclockwise (only for PRO-115)
2. Extract the air filter bladder from the device by pulling it up
3. Extract the filter and replace it with a new one (for example with the help of tweezers)
4. Set the air filter bladder on its place
5. Turn the cover clockwise to fix it (only for the PRO-115)
WARNING! The use of dirty filter or filter made of another material, for example,
cotton, may lead to device damage. Use original filters only.
•Do not use the device without filter.
•Do not try to clean the filter for reusing it. If the filter is wet replace it.
•The air filter shall not be serviced or maintained while in use with a patient.
•To avoid the air filter cover obstruction clean it regularly.
WARNING! Air filters cannot be cleaned or washed.
9. CLEANING, MAINTENANCE AND STORAGE
Cleaning the device and the accessories
The cleaning of the device must be carried out by using a soft and dry cloth and non-
abrasive cleansers.
ATTENTION! During cleaning operations, make sure the internal parts of the unit
are not in contact with liquids and that the power plug is disconnected.
Follow carefully the cleaning and disinfection instructions of the accessories as they are
very important for the device performances and the therapy success.
ATTENTION! Before first using of the device and after each treatment it is
necessary to clean all the accessories according to the following instructions:
•Disassemble the nebulizer by turning counterclockwise the top and remove the medi-
cine conduction cone.
•Wash the components of the disassembled nebulizer, the mouthpiece and nosepiece
by using tap water; dip in boiling water for 5 minutes.
•Reassemble the nebulizer components and connect it to the air-outlet, switch the
device on and let it work for 10-15 minutes or put on the clean paper towel for drying
on the air.
•The masks and air tube must be washed with warm water. Does neither boil nor
autoclave the air tube and masks!
Sterilization:
•Use cold disinfecting liquids following the instructions of the sterilization liquids’
manufacturer.
•Wash your hands and take the components out from disinfection solution, wash the
components in warm running water, lay the components on paper towel and dry.
•Do not wipe disinfected parts of the device with a towel; do not use hair dyer, micro-
wave oven or other household appliances for drying. The outer surface of wet parts
can be wiped with a clean dry cloth.
Caution: In order to avoid spread of infections it is recommended to conduct disinfection
of device components before first and after every use. Use for treatment only the drugs
prescribed by your attending doctor and strictly follow his/her indications.
Opening of the device is prohibited. Repair of the device should be conducted only in
technical service centers recommended by B.Well company.
Note: the nebulizer need to be replaced after 6-12 months depending on the usage.
The nebulizer must be replaced after a long period of inactivity, in case it shows
deformations or breakings, or when the nebulizer nozzle (diffuser) is obstructed by dry
medicine, dust, etc.
Use original nebulizers only.
Maintenance and storage
If you want your device to serve you for years, follow the following indications:
•do not store the device at extremely high or low temperatures, high humidity or under
direct sunlight;
•do not bend or wrap the air tube.
Operation and storage conditions – please see «12. Specification» section
Utilization of the device and any of its components should be performed in accordance
with the local regulations.
10. DISPOSAL
The unit must be disposed in accordance with current standards separately from
domestic wastes.
For disposal it is necessary to contact special organizations licensed to make utilization.
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11. TROUBLESHOOTING
Contact an authorized Customer Service Centre in case you need help about the use and
the maintenance of the equipment.
In case of any malfunction look at the table and try to eliminate it.
Problems Solutions
The device
does not
switch on
• Make sure the power plug is firmly fitted to the wall socket.
• Make sure that the device has been operating within operating
limits indicated in this Instruction for Use (30 min ON / 30 min OFF).
• Make sure that the ends of the air tube are tightly fitted to the main
unit and nebulizer.
• Verify that the nebulizer is not empty or has been filled with the
proper quantity of medicine (max 8 ml). Verify that the nebulizer
nozzle is not obstructed.
The device
does not
nebulize or
nebulizes
weakly
In case of the device not start working properly again, address to authorities Service
center.
Maintenance and repairs
In case of failure, address to qualified personnel authorized by B.Well. Do not open the
device in any case. The unit has no user-serviceable parts within and does not need
internal maintenance or lubrication.
12. SPECIFICATIONS
Power supply: 230 V ~ 50 Hz, 1А
Maximum filling volume: 8 ml
Minimum filling volume: 2 ml
Particle size (MMAD): approx. 3,16 μm
% of particle size <5 μm - more than 70 %
Nebulization rate: 0,4 ml/min.
Residual medicine volume: 1 ml
Noise level: 54 dBA
Weight PRO-110: 1,345 Kg (without accessories)
1, 562 кг (in the gift box with accessories)
Weight PRO-115: 1,510 Kg (without accessories)
1,786 кг. (in the gift box with accessories)
Maximum pressure: 2,2 bar
Size PRO-110 : 137 x 173 x 96mm
Size PRO-115: 224 x 112 x 170 mm
Operation limits: 30 min ON / 30 min OFF
Operating conditions: Temperature: MIN +10 °C - MAX +40 °C
Humidity: MIN 10% RH - MAX 95% RH
Atmospheric pressure: 700 hPa – 1060 hPa
Storage conditions: Temperature: MIN -25 °C – MAX +70 °C
Humidity: MIN 10% RH – MAX 95% RH
Atmospheric pressure: 700 hPa – 1060 hPa
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Instruction for Use
15
PRO-110 / PRO-115
En
11. TROUBLESHOOTING
Contact an authorized Customer Service Centre in case you need help about the use and
the maintenance of the equipment.
In case of any malfunction look at the table and try to eliminate it.
Problems Solutions
The device
does not
switch on
• Make sure the power plug is firmly fitted to the wall socket.
• Make sure that the device has been operating within operating
limits indicated in this Instruction for Use (30 min ON / 30 min OFF).
• Make sure that the ends of the air tube are tightly fitted to the main
unit and nebulizer.
• Verify that the nebulizer is not empty or has been filled with the
proper quantity of medicine (max 8 ml). Verify that the nebulizer
nozzle is not obstructed.
The device
does not
nebulize or
nebulizes
weakly
In case of the device not start working properly again, address to authorities Service
center.
Maintenance and repairs
In case of failure, address to qualified personnel authorized by B.Well. Do not open the
device in any case. The unit has no user-serviceable parts within and does not need
internal maintenance or lubrication.
12. SPECIFICATIONS
Power supply: 230 V ~ 50 Hz, 1А
Maximum filling volume: 8 ml
Minimum filling volume: 2 ml
Particle size (MMAD): approx. 3,16 μm
% of particle size <5 μm - more than 70 %
Nebulization rate: 0,4 ml/min.
Residual medicine volume: 1 ml
Noise level: 54 dBA
Weight PRO-110: 1,345 Kg (without accessories)
1, 562 кг (in the gift box with accessories)
Weight PRO-115: 1,510 Kg (without accessories)
1,786 кг. (in the gift box with accessories)
Maximum pressure: 2,2 bar
Size PRO-110 : 137 x 173 x 96mm
Size PRO-115: 224 x 112 x 170 mm
Operation limits: 30 min ON / 30 min OFF
Operating conditions: Temperature: MIN +10 °C - MAX +40 °C
Humidity: MIN 10% RH - MAX 95% RH
Atmospheric pressure: 700 hPa – 1060 hPa
Storage conditions: Temperature: MIN -25 °C – MAX +70 °C
Humidity: MIN 10% RH – MAX 95% RH
Atmospheric pressure: 700 hPa – 1060 hPa
Cumulative Undersize
(%)
Particle Size (µm)
99.99
99.99
99
95
90
80
70
50
30
20
10
5
1
110
.1
0.1
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Instruction for Use
16
PRO-110 / PRO-115
En
Durable periods:
Durable periods are as follows, provided the product is used to nebulize 2ml of medica-
tion 2 times a day for 5 minutes each time at room temperature (23°C).
Durable period may vary depending on usage environment.
Compressor (main unite) ≥ 10 years (or ~1000 hours)
Nebulizer kit, air tube, mouthpiece, nosepiece, masks – 1 year
Air filter – 60 days
•Class II device as regards protection against electric shocks.
•Nebulizer, mouthpiece and masks are type BF applied parts.
•Device not protected against sprinkles.
•Device for intermittent use (30 min ON / 30 min OFF)
The information defined above is advisory and can change depending on physical prop-
erties (temperature, viscosity, density) of the nebulized substance.
The manufacturer may change technical specifications and design of the device without
prior notice.
13. APPLIED STANDARDS
Electric Safety Standards EN 60601-1. Electromagnetic Compatibility according
to EN 60601-1-2. Class IIa Medical Device according to the 93/42/EEC European Directive
on Medical Devices.
This device fulfils the provision of the EC directive 93/42/EEC (Medical Device Directive)
and the European Standard EN 13544-1:2007+A1:2009 Respiratory therapy equipment -
Part 1: Nebulizing systems and their components.
14. WARRANTY
Warranty period is 3 years from the date of purchase.
This warranty doesn’t cover any damages caused by improper using, and also battery,
protective cover and storage bag, packaging and the accessories supplied with the
device (nebulizer kit, air tube, mouthpiece, nosepiece, masks, air filters) and those parts
subject to normal wear and tear.
The warranty does not apply to damage caused by using adapters not recommended by
the B.Well company and the overvoltage.
When a manufacturing defect is revealed during the warranty period a faulty unit would
be repaired or, if repairing is impossible, replaced with another one.
The manufacturer may change units partially or completely if necessary, without prior
notice.
Manufacturing date is encoded in the SN number at the bottom of the device: two first
numbers are numbers of the week; two other numbers are last numbers of the year.
Manufacturing date of the spare parts, which can be bought separately from the device
is encoded in the LOT number on the sticker: two first numbers are numbers of the
week, two other numbers are last numbers of the year.
15. SYMBOL INFORMATION
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Instruction for Use
17
PRO-110 / PRO-115
En
Durable periods:
Durable periods are as follows, provided the product is used to nebulize 2ml of medica-
tion 2 times a day for 5 minutes each time at room temperature (23°C).
Durable period may vary depending on usage environment.
Compressor (main unite) ≥ 10 years (or ~1000 hours)
Nebulizer kit, air tube, mouthpiece, nosepiece, masks – 1 year
Air filter – 60 days
•Class II device as regards protection against electric shocks.
•Nebulizer, mouthpiece and masks are type BF applied parts.
•Device not protected against sprinkles.
•Device for intermittent use (30 min ON / 30 min OFF)
The information defined above is advisory and can change depending on physical prop-
erties (temperature, viscosity, density) of the nebulized substance.
The manufacturer may change technical specifications and design of the device without
prior notice.
13. APPLIED STANDARDS
Electric Safety Standards EN 60601-1. Electromagnetic Compatibility according
to EN 60601-1-2. Class IIa Medical Device according to the 93/42/EEC European Directive
on Medical Devices.
This device fulfils the provision of the EC directive 93/42/EEC (Medical Device Directive)
and the European Standard EN 13544-1:2007+A1:2009 Respiratory therapy equipment -
Part 1: Nebulizing systems and their components.
14. WARRANTY
Warranty period is 3 years from the date of purchase.
This warranty doesn’t cover any damages caused by improper using, and also battery,
protective cover and storage bag, packaging and the accessories supplied with the
device (nebulizer kit, air tube, mouthpiece, nosepiece, masks, air filters) and those parts
subject to normal wear and tear.
The warranty does not apply to damage caused by using adapters not recommended by
the B.Well company and the overvoltage.
When a manufacturing defect is revealed during the warranty period a faulty unit would
be repaired or, if repairing is impossible, replaced with another one.
The manufacturer may change units partially or completely if necessary, without prior
notice.
Manufacturing date is encoded in the SN number at the bottom of the device: two first
numbers are numbers of the week; two other numbers are last numbers of the year.
Manufacturing date of the spare parts, which can be bought separately from the device
is encoded in the LOT number on the sticker: two first numbers are numbers of the
week, two other numbers are last numbers of the year.
15. SYMBOL INFORMATION
Read instruction before use
Disposal for separate
collection
Type BF equipment
Class II Equipment
CE mark
Serial number
LOT number
Article number
Manufacturer’s Name
Keep dry
Operating condition, temperature
Storage condition, temperature
0044
40
10 OPERATING
condition
-25
70
STORAGE
condition
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Instruction for Use
18
PRO-110 / PRO-115
En
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Guidance and manufacturer’s declaration - electromagnetic emissions
The PRO-110/PRO-115 is intended for use in the electromagnetic environment specified
below. The customer or the user of the PRO-110/PRO-115 should assure that it is used in
such an environment
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The PRO-110/PRO-115 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 PRO-110/PRO-115 is suitable for use
in all establishments other than domestic,
and may be used in domestic establish-
ments and those directly connected to
the public low-voltage power supply
network that supplies buildings used for
domestic purposes, provided the follow-
ing warning is heeded:
WARNING! This equipment/system
is intended for use by healthcare
professionals only. This equipment/
system may cause radio interference or
may disrupt the operation of nearby
equipment. It may be necessary to take
mitigation measures, such as re-orienting
or relocating the PRO-110/PRO-115 or
shielding the location.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Complies
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Instruction for Use
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PRO-110 / PRO-115
En
Guidance and manufacturer’s declaration - electromagnetic emissions
The PRO-110/PRO-115 is intended for use in the electromagnetic environment specified
below. The customer or the user of the PRO-110/PRO-115 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
±6 kV contact
±8 kV air ±6 kV contact
±8 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
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines Mains power quality should be
that of a typical commercial or
hospital environment.
The electrical fast transient
burst (EFT) is generated by
the switching of inductive
loads. Separation between the
equipment and other loads
shall be considered before
installation. Mains filter is
required, if necessary.
Surge
IEC 61000-4-5 ±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s) Mains power quality should be
that of a typical commercial or
hospital environment.
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 cycle
70% UT
(30% dip in UT)
for 25 cycle
<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 cycle
70% UT
(30% dip in UT)
for 25 cycle
<5% UT
(>95% dip in UT)
for 5s
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the PRO-110/
PRO-115 requires continued
operation during power
mains interruptions, it is
recommended the PRO-110/
PRO-115 be powered from an
uninterruptible power supply
or a battery.
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Instruction for Use
20
PRO-110 / PRO-115
En
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: * UT is the a.c. mians voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic emissions
The PRO-110/PRO-115 is intended for use in the electromagnetic environment specified
below. The customer or the user of the PRO-110/PRO-115 should assure that it is used in
such an environment
Immunity Test
IEC 60601
Test level
Compliance
level Electromagnetic environment - guidance
Conducted RF
IEC
61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150KHz to
80MHz
3 V/m
80MHz to
2.5GHz
3V
3 V/m
Portable and mobile RF communications
equipment should be used no closer
to any part ofthe PRO-110/PRO-115,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
3,5
d=[ ] √P
V1
3,5
d=[ ] √P 80MHz to 800 MHz
E1
7
d=[ ] √P 80MHz to 2,5 GHz
E
1
where p is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m)
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tel-
ephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the PRO-110/PRO-115 is used exceeds the ap-
plicable RF compliance level above, the PRO-110/PRO-115 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the PRO-110/PRO-115.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the PRO-110/PRO-115.
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