AWR MN-300/2 User Manual

User Manual AWR Nebulizer MN-300/2

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 3 of 32

Product

AWR Nebulizer MN-300/2
Manufactured in Germany

Distributing Company

AWR Inhalation GmbH
Am Stadtweg 48 B
15834 Rangsdorf
Germany
Email: [e-mail]
Tel.: [phone]
Online: http://www.awr-inhalation.de

Document version

MN-300/2-EN-V3

NOTE:

Please carefully read the user manual before first use of the AWR Nebulizer MN­300/2. Please store the user manual in a safe place.

User Manual AWR Nebulizer MN-300/2

Page 4 of 32 (Version MN-300/2-EN-V3)

Table of Contents

1. Safety Information ........................................................................................................ 5

2. Scope of Delivery, Components of the AWR Nebulizer MN-300/2 .............................. 8

3. LED Displays and Graphical Symbols .......................................................................... 10

4. Intended Use .............................................................................................................. 12

5. Cleaning ...................................................................................................................... 17

6. Power Supply .............................................................................................................. 18

7. Environmental Conditions .......................................................................................... 20

8. Disposal ....................................................................................................................... 21

9. Consumables............................................................................................................... 22

10. Maintenance, Service and Order information ........................................................ 23

11. Technical specifications .......................................................................................... 24

12. Performance Characteristics and Aerosol Spectrum .............................................. 25

13. Information on Electromagnetic compatibility ...................................................... 26

14. EC Declaration of Conformity ................................................................................. 30

15. Warranty ................................................................................................................. 30

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 5 of 32

1. Safety Information

Any use of this device requires exact knowledge of and compliance to this user manual.
Any liability concerning safe function of this device passes to the user in case of
modifications or improper use.

Important information is highlighted by the following terms:

WARNING

Important safety information

- to avoid dangers that can lead to physical harm.

ATTENTION

Important information

- on operation steps that can cause malfunction of the device.

CAUTION

Important information

- to avoid damage to the product.

NOTE

Important information

- you should pay particular attention to this.

WARNING

1. Do not submerge the device under water or other liquids and set the device

up in a way that makes sure it can’t fall into water. Do not use the device if it
has fallen into water. Never attach moist or wet nebulizer units to the
control unit; make sure the nebulizer unit is dry before every use.

2. The device is unsuitable for use in proximity to combustible gases.

3. The device must not come into contact with heated surfaces.

4. The AWR Nebulizer MN-300/2 is not an officially certified medicine product

and therefore not approved for nebulizing medications. Usage and choice of
possible medications for nebulizing can only be determined by the treating
physician. The chosen medications have to be approved by the
manufacturers (pharmaceutical companies) for use with this type of
application (inhalation via ultrasonic nebulizing).

5. An electrical device like this one should never be unattended while

operating. Protect the device from unauthorized access. Special caution is
required if the device is operated by or in proximity to children or severely ill
persons.

6. The consumables must not be used by multiple persons for reasons of

hygiene. Every person should use their own personal nebulizer unit as well as
a personal mouth piece.

User Manual AWR Nebulizer MN-300/2

Page 6 of 32 (Version MN-300/2-EN-V3)

7. Only use accessories certified by the distributing company of this device. Do

not attach accessories which are not recommended by the distributing
company.

8. Do not open the case. Any repair or maintenance may only be performed by

a service provider who was qualified by the distributing company of this
device. Failure to comply results in loss of all warranty claims.

9. The device and the accessories must not be used in case of visible damage or

defects. This device must not be operated if:

a. The power cable or plug are damaged.
b. The device is not working properly.
c. The device has been dropped or damaged.
d. The device has been dropped into water.

In such cases, the device has to be shipped to a service provider who was
qualified by the distributing company of this device for inspection and repair.

ATTENTION

1. Check the remaining battery capacity before every use.

2. Make sure before every use that the medication has been filled into the

nebulizer unit.

3. Please make sure to always hold the AWR Nebulizer MN-300/2 during

nebulizing in a way that the liquid always directly touches the silver
membrane of the nebulizer unit. If an air bubble forms behind the metal
membrane or if no liquid touches the membrane, the control unit will switch
off automatically.

4. Over the course of their uses, the nebulizer units can change their technical

properties (technical wear and tear). This can negatively affect the
properties of the produced aerosol. Furthermore, the nebulizer units should
be replaced regularly for reasons of hygiene. Depending on use frequency,
the nebulizer unit should be replaced by a new nebulizer unit after a
maximum use period of 1-3 months. Our recommendation:

a. A monthly replacement for daily use.
b. A replacement every three months at the latest.

5. The device must not be used for purposes other than those listed on this

user manual.

6. The control unit is exclusively powered by the internal rechargeable battery.

7. During operation of this device, proper functioning of the nebulizer has to be

ensured and checked.

CAUTION

1. Do not touch the aerosol generator within the nebulizer unit.

2. Do not insert objects into the nebulizer unit or other openings..

3. The USB port of the control unit exclusively serves as a port for the nebulizer

unit. Do not attach other standard USB cables to this USB port of the control
unit.

4. To avoid damaging the product, the battery must exclusively be charged with

the original power adapter or the original USB charging cable.

5. The power cable has to be kept away from heated surfaces.

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 7 of 32

NOTES

1. Please inspect the delivery for completeness before first operation of the

device. Also inspect the delivered components for visual defects such as
contamination, stress cracks or damage.

2. The control unit my warm up in case of prolonged use.

3. Maximum runtime for the manual mode is 2 hours. Maximum runtime for

the continuous mode is 1 hour. Maximum standby time (ready to start the
continuous or manual mode) is 60 seconds. If the maximum runtime for
either mode is reached, the device is shut down automatically.

4. Depending on the initial state, the charging time for the internal,

rechargeable battery (lithium-ion battery) of the control unit is about 2 hours
for 80% charging capacity and about 3 hours for 100% charging capacity.

5. This product is subject to the Federal German law concerning distribution,

take-back and environmentally sound disposal of electric and electronic
devices (Elektro- and Elektronikgesetz – ElektroG). For this reason, the
electronic components of the AWR Nebulizer MN-300/2 (control unit and
power adapter) must not be disposed as domestic waste. Disposal of these
electronic components has to meet local disposal policies. Subject to the
German waste catalogue ordinance (Abfallverzeichnis-Verordnung – AVV),
waste code 20 01 39 (separately collected fractions, synthetic materials), the
nebulizer unit can be disposed with municipal waste.

User Manual AWR Nebulizer MN-300/2

Page 8 of 32 (Version MN-300/2-EN-V3)

2. Scope of Delivery, Components of the AWR Nebulizer MN-300/2

Please take some time to familiarize yourself with your device and the accessories,
before using your AWR Nebulizer MN-300/2 for the first time.

NOTE

Please inspect the delivery for completeness before first operation of the AWR
Nebulizer MN-300/2. Also inspect the delivered components for visual defects
such as contamination, stress cracks or damage. The AWR Nebulizer MN-300/2
or its components must not be used if they display visual defects or damage.
Contact the distributing company in such cases.

The following table lists all components of the AWR Nebulizer MN-300/2:

Article #

Description

Image

201 102 01

Control unit AWR
Nebulizer MN-300/2

201 102 04

Nebulizer unit AWR
Nebulizer MN-300/2

MMD: 4.0 µm

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 9 of 32

Article #

Description

Image

201 102 05

Power adapter AWR
Nebulizer MN-300/2

201 102 02

Optionally available:

USB charging cable AWR
Nebulizer MN-300/2

201 102 06

Optionally available:

Nebulizer unit AWR
Nebulizer MN-300/2

MMD: 6.0 µm

201 102 07

Optionally available:

Mouth piece AWR
Nebulizer MN-300/2

User Manual AWR Nebulizer MN-300/2

Page 10 of 32 (Version MN-300/2-EN-V3)

3. LED Displays and Graphical Symbols

This chapter lists the graphical symbols and LED displays you find on your AWR Nebulizer
MN-300/2, the accessories, this user manual and the packaging.

Graphical symbols on the packaging:

Image

Definition

Do not use if packaging has been damaged

Keep away from sunlight

Keep dry

Temperature limit: Indicates the safe temperature range for the
medical product

Atmospheric pressure limit: Indicates the safe atmospheric
pressure range for the product

Air humidity limit: Indicates the safe air humidity range for the
product

LED displays of the control unit:

Symbol

LED display

Meaning

Battery
status
indicator

The LED:

- shows a green light when operating the device with
battery capacity over 30 %

- switches between green and red if the battery capacity is
above 10 % and below 30 %

- shows a red light if the battery capacity is below 10 %.

- shows a slow green flashing (intervals of 1s / 1s) if the
charging process is active

- shows a short green flashing (intervals of 0.1s / 0.1s) if
the charging process has been completed

Operating
mode
indicator

The LED:

- Shows three short blue flashes when the boot process
has been completed

- Shows a continuous blue light during nebulizing (in the
continuous mode as well as the manual mode)

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 11 of 32

Graphical symbols on the control unit:

Image

Definition

On/Off button

Start/Stop button

Distributing company: Shows distributing company of the product

Serial number: Shows the serial number designated by the
distributing company in order to make identification of a single
control unit possible

CE Label plus identification number of the authority that was
responsible for the conformity assessment procedure

Article number: Shows the order number designated by the
distributing company in order to identify the article

Type B applied part

Device of protection class II

Observe the instructions of the user manual: Reiterates the
necessity for users to refer to the user manual

Attention: Reiterates the necessity for users to look through to the
user manual for important, safety-related information, such as

warning notices and precautions which can’t be printed on the

control unit itself for a variety of reasons

Do not dispose as regular household waste

DC power input

Start
Stop

User Manual AWR Nebulizer MN-300/2

Page 12 of 32 (Version MN-300/2-EN-V3)

4. Intended Use

The AWR Nebulizer MN-300/2 is a nebulizer designed to introduce exact doses of liquids
in the form of aerosol into the airways of the lungs.

WARNING

The AWR Nebulizer MN-300/2 is not an officially certified medicine product and
therefore not approved for nebulizing medications. Usage and choice of possible
medications for nebulizing can only be determined by the treating physician. The
chosen medications have to be approved by the manufacturers (pharmaceutical
companies) for use with this type of application (inhalation via ultrasonic
nebulizing).

Step 1: Filling the nebulizer unit:

The liquid recommended for inhalative lung care is a 0.9 % saline solution.

- Open the sealing cap by turning it 80 degrees

counter-clockwise and then lifting it up.

- Fill the liquid into the chamber.

- Re-attach the sealing cap and close it by turning

it 80 degrees clockwise.

NOTE

The initial setup for the AWR Nebulizer MN-300/2 is being described here for use
with the nebulizer unit with an MMD of 4.0 µm. This information, however, is
also valid for the use with the optionally available nebulizer unit with an MMD of

6.0 µm.

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 13 of 32

Step 2: Connecting the nebulizer unit to the control unit:

- Connect the filled nebulizer unit to the control

unit by connecting the female USB connector of
the control unit with the male USB connector of
the nebulizer unit.

Step 3: Starting the Control Unit:

- Press the on/off button of the control

unit for a prolonged period (> 1
second). The control unit starts up.
This is indicated by a short acoustic
signal and the battery status indicator
shows a continuous green light.

- Operational readiness of the AWR

Nebulizer MN-300/2 is provided
when the operating mode indicator
has shown three short blue flashes.

PRESS and HOLD

User Manual AWR Nebulizer MN-300/2

Page 14 of 32 (Version MN-300/2-EN-V3)

Step 4: Changing the Operating Mode:

The AWR Nebulizer MN-300/2 comes with two nebulizing modes (manual mode and
continuous mode).

Manual mode (standard setting)

In the manual mode, pressing the start/stop button on the control unit starts aerosol
production. The blue LED of the operating mode indicator lights up with each phase of
aerosol production. The manual mode is the standard setting of the device.

Continuous mode

In the continuous mode, the device continuously produces aerosol. The blue LED of the
operating mode indicator on the control unit continuously lights up as long as aerosol is
being produced.

NOTE

The standard setting for the AWR Nebulizer MN-300/2 is the manual mode.
When you switch on the AWR Nebulizer MN-300/2 and it’s ready for operation,
the AWR Nebulizer MN-300/2 will be in manual mode.

You can perform the switch from manual to continuous mode within a timeframe of 60
seconds after startup or last manual nebulizing. This corresponds to the maximum
standby time.

- Please now press the on/off button of

the control unit briefly (< 1 second). You
will hear two short acoustical signals in
quick succession and the operating
mode indicator shows a continuous blue
light. The AWR Nebulizer MN-300/2 is
now set to continuous mode and will
nebulize continuously (if liquid has been
filled into the nebulizer unit).

- If you’d like to switch back from the

continuous mode to the manual mode,
again press the on/off button of the control unit briefly (< 1 second). You will
hear a short acoustical signal and the blue LED of the will go out, flash shortly
three times and will then go out again.

Press BRIEFLY

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 15 of 32

Step 5: Starting the nebulizing and performing the inhalation:

- Breathe out first.

- Then press the start/stop button to

start the aerosol production (not in
continuous mode).

- Inhale the produced aerosol.

- Release the start/stop button as soon

as the inhalation process is complete
(not in continuous mode).

- Breathe out. Do not breathe out through the mouth piece but remove it from

your mouth when you breathe out.

- Repeat this process until the filled liquid has fully been aerosolized. The

control unit will then switch off automatically.

NOTE

During each production phase for aerosol, the operating mode indicator lights up
blue for the whole duration of the aerosol production.

ATTENTION

Please make sure to always hold the AWR Nebulizer MN-300/2 during nebulizing
in a way that the liquid always directly touches the silver membrane of the
nebulizer unit. If an air bubble forms behind the metal membrane or if no liquid
touches the membrane, the control unit will switch off automatically.

Press

Start

Stop

User Manual AWR Nebulizer MN-300/2

Page 16 of 32 (Version MN-300/2-EN-V3)

Step 6: Switching off the control unit:

To abort or pause nebulizing, the AWR Nebulizer MN-300/2 has to be switched off.

- To do this, press the on/off button of

the control unit for a prolonged
period (> 1 second). The AWR
Nebulizer MN-300/2 then switches
off. This is indicated by a short
acoustic signal and the battery status
indicator stops shining.

NOTE

The AWR Nebulizer MN-300/2 can be automatically switched off by two built-in
switch-off mechanisms. These are the automatic switch-off and the maximal
runtimes of the AWR Nebulizer MN-300/2.

The automatic switch-off switches the AWR Nebulizer MN-300/2 off automatically
regardless of the chosen nebulizing mode as soon as the filled liquid has fully been
nebulized.

The maximal runtimes switch off the AWR Nebulizer MN-300/2 automatically, as soon as
the respective maximal durations have been reached:

- Maximum runtime for the manual mode is 2 hours.

- Maximum runtime for the continuous mode is 1 hour.

- Furthermore, the maximum standby time (readiness to start the continuous

or manual nebulizing mode) will switch off the AWR Nebulizer MN-300/2
after 60 seconds without any activity.

PRESS and HOLD

User Manual AWR Nebulizer MN-300/2

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5. Cleaning

Cleaning the control unit of the AWR Nebulizer MN-300/2:

Use a moist cloth to wipe down the case of the control unit. Afterwards, dry the case of
the control unit with a dry cloth or let it air dry on a dry absorbent underlay.

WARNING

Make sure before every cleaning or the control unit that the power adapter has
been disconnected. Never submerge the control unit into water or cleaning
solutions.

Cleaning the nebulizer unit of the AWR Nebulizer MN-300/2:

NOTE

The cleaning process for the nebulizer unit described here refers to both the
AWR Nebulizer MN-300/2 nebulizer unit with an MMD of 4.0 µm and the
optionally available AWR Nebulizer MN-300/2 nebulizer unit with an MMD of 6.0
µm.

Clean the nebulizer unit by filling a small amount (0.5 ml to 2.0 ml max.) of distilled or
sterile water into the chamber and have the device nebulize it in continuous mode.

WARNING

Do not inhale the nebulized distilled or sterile water. Make sure the room where
you’re cleaning the device is sufficiently ventilated.

Remove the sealing cap from the nebulizer unit after the liquid has fully been nebulized
and place the nebulizer unit onto a dry absorbent underlay to air dry it.

Cleaning the mouth piece of the AWR Nebulizer MN-300/2:

Rinse the mouth piece in warm tap water. Let it then air dry on an absorbent and dry
underlay.

User Manual AWR Nebulizer MN-300/2

Page 18 of 32 (Version MN-300/2-EN-V3)

6. Power Supply

The control unit of the AWR Nebulizer MN-300/2 is powered by the internal
rechargeable battery (lithium-ion battery).

The battery status indicator of the control unit shows you the charging status of the
AWR Nebulizer MN-300/2:

- The battery status indicator will show a continuous green light if the battery

capacity is above 30 %

- The battery status indicator will switch between a red and a green light if the

battery capacity is below the threshold of 30 %

- The battery status indicator will show a continuous red light if the battery

capacity falls below the threshold of 10 %. The AWR Nebulizer MN-300/2 will
switch off automatically. The battery has to be recharged if the battery
capacity falls below the threshold of 10 %.

ATTENTION

The charging process for the internal rechargeable battery (lithium-ion battery)
must only be performed with the provided power adapter or the optionally
available USB charging cable to avoid damaging the device.

Recharging via power adapter

Recharging via USB charging cable

For the charging process, plug the power
adapter into the control unit first. Then
plug the power adapter into the power
outlet.

For the charging process, plug the USB
charging cable into the control unit first.
Then, connect the USB charging cable to a
standard USB charging adapter. Then,
plug the charging adapter into the power
outlet.

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 19 of 32

- While the battery of the control unit is being charged, the battery status

indicator will show slow green flashing (1 second green / 1 second pause).

- If the battery of the control unit has fully been charged the battery status

indicator will show short green flashing (0.1 seconds green / 1 second pause).

NOTE

Depending on the initial state, the charging time for the internal, rechargeable
battery (lithium-ion battery) of the control unit for the AWR Nebulizer MN-300/2
is about 2 hours for 80% charging capacity and about 3 hours for 100% charging
capacity.

ATTENTION

The internal rechargeable battery (lithium-ion battery) of the AWR Nebulizer
MN-300/2 will only reach full potential after 2–3 full charge cycles. Occasionally,
new control units may switch of on their own during nebulizing. This issue
resolves itself after 2–3 full charge cycles.

User Manual AWR Nebulizer MN-300/2

Page 20 of 32 (Version MN-300/2-EN-V3)

7. Environmental Conditions

Described below are the environmental conditions which have to be maintained to
ensure proper functioning of the AWR Nebulizer MN-300/2 in its intended use.

Operating conditions:

Reliable operation of the device is guaranteed under the following environmental
conditions:
Ambient air temperature: +10 °C to +40 °C or +50 °F to +104 °F
Relative air humidity: 25 % to 75 %
Atmospheric pressure: 450 hPa to 1100 hPa

Shipping and storage conditions:

Shipping and storage of the device are guaranteed under the following environmental
conditions:
Ambient air temperature: -10 °C to +50 °C or +14 °F to +122 °F
Relative air humidity: 25 % to 75 %
Atmospheric pressure: 450 hPa to 1100 hPa

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 21 of 32

8. Disposal

This product is subject to the Federal German law concerning distribution, take-back and
environmentally sound disposal of electric and electronic devices (Elektro- and
Elektronikgesetz – ElektroG).

For this reason, the electronic components of the AWR Nebulizer MN-300/2 (control
unit and power adaptor) must not be disposed as domestic waste. Disposal of these
electronic components has to meet local disposal policies.

Subject to the German waste catalogue ordinance (Abfallverzeichnis-Verordnung – AVV),
waste code 20 01 39 (separately collected fractions, synthetic materials), the nebulizer
units for the AWR Nebulizer MN-300/2 can be disposed with municipal waste.

User Manual AWR Nebulizer MN-300/2

Page 22 of 32 (Version MN-300/2-EN-V3)

9. Consumables

Die nebulizer units with an MMD of 4.0 and 6.0 µm as well as the mouth piece of the
AWR Nebulizer MN-300/2 are consumables.

The consumables can be supplied by the distributing company.
(www.awr-inhalation.de).

WARNING

The consumables must not be used by multiple persons for reasons of hygiene.
Every person should use their own personal nebulizer unit as well as a personal
mouth piece.

ATTENTION

Over the course of their uses, the nebulizer units can change their technical
properties (technical wear and tear). This can negatively affect the properties of
the produced aerosol. Furthermore, the nebulizer units should be replaced
regularly for reasons of hygiene.
Depending on use frequency, the nebulizer unit should be replaced by a new
nebulizer unit after a maximum use period of 1-3 months. Our recommendation:

- A monthly replacement for daily use.

- A replacement every three months at the latest.

User Manual AWR Nebulizer MN-300/2

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10. Maintenance, Service and Order information

If the AWR Nebulizer MN-300/2 has been damaged or stops working properly, it should
be examined and a technical safety inspection should be performed.

WARNING

Do not open the case. Any repairs or maintenance must only be performed by
the distributing company. Failure to heed this information may lead to loss of
warranty.

Please contact the distributing company if you need technical service or advice.

Replacement parts and consumables, especially the nebulizer units with an MMN of 4.0
µm and 6.0 µm which have to be replaced regularly, can be obtained via the online shop
of the distributing company or specialist retailers.

AWR Inhalation GmbH

Am Stadtweg 48 B
15834 Rangsdorf
Deutschland
Tel.: [phone]
Email: [e-mail]
Online: www.awr-inhalation.de

User Manual AWR Nebulizer MN-300/2

Page 24 of 32 (Version MN-300/2-EN-V3)

11. Technical specifications

Control unit AWR Nebulizer MN-300/2:

Size 85 x 54 x 18 mm
Weight 75 g
Electrical supply Internal: 3.6 V/500 mA; external: 5 V/1.2 A
Power consumption in use Maximum of 500 mA
Operating frequency 110 kHz
Nebulizer capacity < 0.6 ml/min
MMAD < 4.0 µm
Electrical protection class Class II, type B
Type of battery used Lithium-ion battery, 3.7 V, 1200 mAh

Power adapter AWR Nebulizer MN-300/2:

Size 74 x 44 x 73 mm
Cable length 1.8 m
Weight 165 g

Nebulizer unit MMD 4.0 µm AWR Nebulizer MN-300/2:

Size 57 x 56 x 30 mm
Maximum filling capacity 8 ml
Weight 20 g

Nebulizer unit MMD 6.0 µm AWR Nebulizer MN-300/2:

Size 57 x 56 x 30 mm
Maximum filling capacity 8 ml
Weight 20 g

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 25 of 32

12. Performance Characteristics and Aerosol Spectrum

Aerosol delivery as well as particle size have been evaluated and determined for the
AWR Nebulizer MN-300/2 in accordance with DIN EN 13544-1, appendix CC.

Performance characteristics and aerosol spectrum for the AWR Nebulizer MN-300/2
when using the nebulizer unit with an MMD of 4.0 µm:

Aerosol delivery as per DIN EN 13544-1, appendix CC – CC.1.4 is 1.17 +/- 0.04 mg sodium
chloride per minute. Aerosol delivery as per DIN EN 13544-1, appendix CC – CC.2 is 1.86
mg sodium chloride per minute. This is equivalent to an aerosol delivery of 0.4 ml
sodium chloride per minute.

The average particle size as per DIN EN 13544-1, appendix CC is 3.68 μm MMD with a
GSD of 1.64.

Performance characteristics and aerosol spectrum for the AWR Nebulizer MN-300/2
when using the nebulizer unit with an MMD of 6.0 µm:

Aerosol delivery as per DIN EN 13544-1, appendix CC – CC.1.4 is 5.0 +/- 0.02 mg sodium
chloride per minute. Aerosol delivery as per DIN EN 13544-1, appendix CC – CC.2 is 2.97
mg sodium chloride per minute. This is equivalent to an aerosol delivery of 0.57 ml
sodium chloride per minute

The average particle size as per DIN EN 13544-1, appendix CC is 6.32 μm MMD with a
GSD of 2.00.

User Manual AWR Nebulizer MN-300/2

Page 26 of 32 (Version MN-300/2-EN-V3)

13. Information on Electromagnetic compatibility

Guidance and manufacturer's declaration – electromagnetic emissions:

The nebulizer is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below. The
customer or user should make sure that it is being operated in such an environment.

Measurements on emitted
interferences

Conformity

ELECTROMAGNETIC ENVIRONMENT –
Guidance

HF emission as per
CISPR 11

Group 1

The nebulizer utilizes HF energy exclusively for
its internal FUNCTION. Thus, its HF emission is
very low and electromagnetic interferences
with electronic devices in the proximity are
unlikely.

HF emission as per
CISPR 11

Class B

The nebulizer is suitable for use in any type of
facilities, including living quarters and those
that are directly connected to a PUBLIC SUPPLY
NETWORK which also supplies buildings that
are used for residential purposes.

Harmonics emissions as per IEC
61000-3-2

Class A

Emission of voltage
fluctuations and flicker as per
IEC 61000-3-3

Conforms

WARNING

The AWR Nebulizer MN-300/2 must not be used in immediate proximity to other
devices. If this is necessary, the device should be monitored to ensure proper
function in this operational setup.

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 27 of 32

Guidance and manufacturer's declaration – electromagnetic immunity:

The nebulizer is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below. The
customer or user should make sure that it is being operated in such an environment.

Measurements on
interference
immunity

Testing level as per
IEC 60601

Compliance level

Electromagnetic environment –
guidelines

Static electrical
discharge (ESD) as
per IEC 61000-4-2

+ 6 kV contact
discharge

+ 8 kV air discharge

+ 6 kV contact
discharge

+ 8 kV air discharge

Floors should be made of wood,
concrete, or ceramic tiles. If the
flooring is synthetic, the relative
air humidity must be at least
30%.

Fast transient
electrical bursts as
per IEC 61000-4-4

+ 2 kV for power
supply lines
+ 1 kV for input lines
and output lines

+ 2 kV for power
supply lines
+ 1 kV for input lines
and output lines

The quality of the supply
voltage should be to the
standard of a typical business or
hospital environment.

Surge voltage as
per IEC 61000-4-5

+ 1 kV voltage
external conductor to
external conductor
+ 2 kV external
conductor to earth

+ 1 kV voltage
external conductor to
external conductor
+ 2 kV external
conductor to earth

The quality of the supply
voltage should be to the
standard of a typical business or
hospital environment.

Voltage dips, short
interruptions and
voltage variations
as per IEC 61000-4­11

< 5% UT (> 95%
voltage dip of UT) for
½ period
40% UT (60% voltage
dip of UT) for 5
periods
70% UT (30% voltage
dip of UT) for 25
periods
< 5% UT (> 95%
voltage dip of UT) for
5 s

< 5% UT (> 95%
voltage dip of UT) for
½ period
40% UT (60% voltage
dip of UT) for 5
periods
70% UT (30% voltage
dip of UT) for 25
periods
< 5% UT (> 95%
voltage dip of UT) for
5 s

The quality of the supply
voltage should be to the
standard of a typical business or
hospital environment. If the
user of the nebulizer requires
continued operation even when
interruptions of the power
supply occur it is recommended
to power the nebulizer with an
interruption free power supply
or via battery.
NOTE: UT is the AC mains voltage prior to application of the test level.

Magnetic field of
the power
frequency (50/60
Hz) as per 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.

User Manual AWR Nebulizer MN-300/2

Page 28 of 32 (Version MN-300/2-EN-V3)

Portable and mobile RF communications equipment should be used no closer to the nebulizer including
its cable than the recommended safety distance calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance:

Measurements on
interference
immunity

Testing level as per
IEC 60601

Compliance level

Electromagnetic environment –
guidelines

Conducted HF
interferences as
per IEC 61000-4-6

3V

eff

150 kHz to 80 MHz

3V

eff

D = 1.2 √ P

Radiated HF
interferences as
per IEC 61000-4-3

3 V/m
80 MHz to 2.5 GHz

3 V/m

D = 1.2 √ P 80 MHz to 800 MHz
D = 2.3 √ P 800 MHz to 2.5 GHz
P is the rated output of the
transmitter in watts (W)
according to the transmitter
manufacturer and D is the
recommended safety distance
in meters (m). Field strengths
from fixed RF transmitters, as
determined by an
electromagnetic site surveya
should be less than the
compliance levelb in each
frequency range. Interference
may occur in the vicinity of
equipment marked with:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. The emanation of electromagnetic variables is
affected by absorption and reflection by buildings, objects and persons.

a) Field strengths from fixed RF transmitters, for example base stations of wireless telephones, amateur
radio stations, land mobile radios as well as AM and FM radio and TV broadcasts cannot be predicted
theoretically with high accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be carried out. If the measured field strength in the
location in which the nebulizer is used exceeds the compliance levels above, the nebulizer should be
monitored to verify normal OPERATION. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the nebulizer.
b) Within a frequency range of 150 kHz to 80 MHz, the field strength should be below 3 V/m.

User Manual AWR Nebulizer MN-300/2

(Version MN-300/2-EN-V3) Page 29 of 32

Recommended safety distances between portable and mobile HF telecommunications devices and
the nebulizer:

Der nebulizer is intended for operation in an electromagnetic environment in which high-frequency
interference variables are controlled. The customer or user of the nebulizer can help avoid
electromagnetic interference by maintaining the following minimum safety distances between portable
and mobile high-frequency telecommunication devices (transmitters) and the nebulizer – depending on
the output power of the communications equipment.

Output power of

transmitter in

W

Safety distance depending om the transmitted frequency

150 kHz to 80 MHz

D = 1,2 √ P

80 MHz to 800 MHz

D = 1.2 √ P

800 MHz to 2.5 GHz

D = 2.3 √ P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73 1 1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters whose maximum power output is not covered by the table above, the recommended
safety distance D in meters (m) can be calculated using the formula given in the respective column,
whereby P is the maximum power output of the transmitter in Watts (W) as per the information given
by the manufacturer of the transmitter.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. The emanation of electromagnetic variables is
affected by absorption and reflection by buildings, objects and persons.

User Manual AWR Nebulizer MN-300/2

Page 30 of 32 (Version MN-300/2-EN-V3)

14. EC Declaration of Conformity

Product AWR Nebulizer MN-300/2
REF MN-300/2

Distributing company AWR Inhalation GmbH

Am Stadtweg 48 B, 15834 Rangsdorf

Directive EC Directive 89/336/EWG (electromagnetic compatibility)

EC Directive 73/23/EWG (electrical equipment designed for
use within certain voltage limits)

We, the distributing company, hereby declare conformity of the abovementioned
product as per the EC directives 89/336/EWG (electromagnetic compatibility) and
73/23/EWG (electrical equipment designed for use within certain voltage limits.

15. Warranty

We grant you a 24-months warranty starting on the date of the purchase for your AWR
Nebulizer MN-300/2. This warranty applies to the control unit of the AWR Nebulizer
MN-300/2 and power adapter of the AWR Nebulizer MN-300/2.

We grant you a 6-months warranty on the integrated battery cells of the control unit of
the AWR Nebulizer MN-300/2.

The AWR Inhalation MN-300/2 nebulizer units with an MMD of 4.0 µm and the AWR
Inhalation MN-300/2 nebulizer units with an MMD of 6.0 µm wear parts and therefore
excluded from the warranty.

Damages caused by inappropriate handling of the device are not covered by this
warranty. The warranty will automatically become void in case of tampering or foreign
modifications on the device.

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