M-neb Dose+ User manual

ultrasonic nebulizer
Instructions for use:
M-neb®dose+mesh nebulizer MN-300/8

- 2 -

- 3 -
Manufacturer
NEBU-TEC med. Produkte Eike Kern GmbH
Kreuzfeldring 17
63820 Elsenfeld –GERMANY
Tel.: (+49) (0) 6022 –610 62 0
Fax: (+49) (0) 6022 –610 62 99
Email: [email protected]
Web: http://www.nebu-tec.de
M-neb®dose+
mesh nebulizer
MN-300/8
Made in Germany

- 4 -
Table of contents
1.0 Icons..............................................................................................................................................5
2.0 Safety information........................................................................................................................7
3.0 Intended use.............................................................................................................................. 11
3.1 Functional description of the M-neb®dose+mesh nebulizer MN-300/8 ..................................... 11
3.2 Nebulizer modes ......................................................................................................................... 11
3.2.1 Triggered mode........................................................................................................................... 11
3.2.2 Continuous mode........................................................................................................................ 12
3.3 Automatic switch-off.................................................................................................................... 12
3.4 Maximum runtimes:..................................................................................................................... 12
4.0 Delivery scope of the M-neb®dose+mesh nebulizer MN-300/8 ........................................... 13
5.0 The most important components of your M-neb®dose+mesh nebulizer MN-300/8 .......... 14
6.0 Start-up of the M-neb®dose+mesh nebulizer MN-300/8....................................................... 15
6.1 Filling the M-neb®dose+nebulizer unit MN-300/8...................................................................... 15
6.2 Connect M-neb®dose+nebulizer unit MN-300/8 with the M-neb®dose+mesh nebulizer MN-300/8
(control unit) ................................................................................................................................ 16
6.3 Start medication nebulisation and carry out inhalation ............................................................... 17
6.4 Switch off M-neb®dose+mesh nebulizer MN-300/8................................................................... 19
6.5 Changing the operating modes................................................................................................... 20
6.6 Use of the continuous mode ....................................................................................................... 22
7.0 Power supply............................................................................................................................. 23
8.0 Charging of the M-neb®mesh nebulizer MN-300/8 (control unit)......................................... 23
9.0 Cleaning..................................................................................................................................... 27
9.1 Cleaning the M-neb®dose+mesh nebulizer MN-300/8 (control unit)......................................... 27
9.2 Cleaning of the M-neb®dose+nebulizer unit MN-300/8 and the M-neb®dose+mouthpiece MN-
300/8 ........................................................................................................................................... 27
10.0 Maintenance .............................................................................................................................. 28
11.0 Diode displays........................................................................................................................... 29
12.0 Ambient conditions................................................................................................................... 29
12.1 Operating conditions ................................................................................................................... 29
12.2 Transport and storage conditions ............................................................................................... 29
13.0 Duration of use.......................................................................................................................... 30
14.0 Disposal ..................................................................................................................................... 30
15.0 Technical specifications........................................................................................................... 31
16.0 Performance data...................................................................................................................... 31
17.0 Aerosol spectrum...................................................................................................................... 32
18.0 Accessories/Ordering information.......................................................................................... 32
19.0 Service ....................................................................................................................................... 32
20.0 Manufacturer ............................................................................................................................. 32
21.0 Information on electromagnetic compatibility....................................................................... 33
22.0 EC Certificate of Conformity.................................................................................................... 36
23.0 Warranty..................................................................................................................................... 36
24.0 Release notes............................................................................................................................ 36

- 5 -
1.0 Icons
The icons are shown below that you see on your M-neb®dose+mesh nebulizer MN-300/8,
the respective accessories and their packaging.
Figure
Definition
Manufacturer; displays the
manufacturer of the medical device.
Caution; stresses the need for the
user to review the instructions for use
on important safety-related
information such as warnings and
precautions which cannot be applied
to the medical device for a variety of
reasons.
Device of protection class II
Type B applied part
0197
CE mark including designation of the
identification number of the notified
body which has performed the
conformity assessment procedure.
Follow instructions for use; stresses
the need for the user to consult the
instructions for use.
Do not dispose of in normal
household waste.
Item number; displays the order
number of the manufacturer, so that
the medical device can be identified.
Batch number; displays the batch
number of the manufacturer, so that
the lot can be identified.
Serial number; displays the serial
number of the manufacturer, so that a
specific medical device can be
identified.

- 6 -
Figure
Definition
DC connection
Battery status indicator
(Explanation on this in Chapter 11.0 Diode
displays)
Operating mode status indicator
(Explanation on this in Chapter 11.0 Diode
displays)
On/off button
Do not use if packaging is damaged;
displays a medical product that
should not be used if the packaging
is damaged or opened.
Keep away from sunlight; designates
a medical device that needs
protection from light sources.
Store in a dry place; designates a
medical device that must be
protected against moisture.
Temperature range; the temperature
range is designated in which the
medical device can be safely used.
Air pressure range; identifies the
range of atmosphere pressure in
which the medical device can be
safely used.
Humidity range; identifies the range
of humidity to which the medical
device can be safely exposed.

- 7 -
2.0 Safety information
Each handling of this device assumes precise knowledge and observance of these
instructions for use.
Liability for the safe operation of the device passes in any case to the operator if a third-
party intervention is carried out or a handling which does not correspond to the intended
use.
Important information is highlighted by the following expressions:
WARNING
Important safety information on hazards that can cause personal injury.
ATTENTION
Important information on operation steps that can cause malfunctions of the device.
CAUTION
Information, which prevents damage to the product.
NOTE
Information, which you should pay special attention to.
NOTE
Please carefully read through the instructions for use before first use of the M-neb®dose+
mesh nebulizer MN-300/8. Store the instructions for use carefully.

- 8 -
WARNING
1. Do not immerse the device in water or any other liquids.
2. Place the device so that it cannot fall into water.
3. Do not use the device if it has fallen into water.
4. Do not use the device while bathing.
5. The device is not suitable for use in the vicinity of flammable, aesthetic mixtures
with air or nitrous oxide.
6. Do not bring the device into contact with heated surfaces.
7. The medications used must be approved for use with aerosols by the drug
manufacturers. Only medications prescribed by the physician which are approved
for use with medication nebulizers may be used.
8. Before beginning each treatment and before each use, check the battery level of
the device.
9. Only use accessories certified by the manufacturer.
10. Protect the device against uncontrolled access.
11. Ensure that the medication has been filled in the nebulizer unit prior to starting
treatment.
12. Ensure that the device's internal battery has been charged prior to starting
treatment.
13. Never connect humid or wet nebulizer units to the control unit; prior to each use
check that the nebulizer unit is dry.
14. The M-neb®dose+mesh nebulizer MN-300/8 may not be placed directly next to
other devices. If necessary, the device should be observed to verify its proper
operation in the configuration used.
15. Do not open the housing. All repairs or maintenance may only be done by a dealer
qualified by NEBU-TEC med. Produkte Eike Kern GmbH. Failure to observe this
leads to the loss of the warranty claim.
16. Do not operate the M-neb®flow mesh nebulizer MN-300/3 when damage or
defects to the M-neb®power cord MN-300/X (type: GTM41076-0605-A) are visible.
17. Protect the device and its accessories against uncontrolled access.
ATTENTION
1. An electrical device such as the M-neb®dose+mesh nebulizer MN-300/8 should
never be operated unattended.
2. Special caution is required if the device is used by or in the vicinity of children or
seriously ill patients.
3. The device is exclusively and only to be used for the intended purposes listed in
these instructions for use. Do not use accessories that are not recommended by
the manufacturer.
4. Never operate this device when:
a) the power cord or the plug is damaged.
b) the device does not function properly.
c) the device has been dropped or damaged.
d) the device has fallen in water.
In such cases, the device is to be sent to a dealer qualified by NEBU-TEC med.
Produkte Eike Kern GmbH for the purpose of inspection and repair.
5. Keep the power cord away from heated surfaces.
6. Never insert objects into openings.
7. The device is not suitable for use in the vicinity of flammable, aesthetic mixtures
with air or nitrous oxide.

- 9 -
8. The M-neb®dose+mesh nebulizer MN-300/8 (control unit) is operated exclusively
via the internal, rechargeable battery.
9. Only use the supplied M-neb®power cord MN-300/X (type: GTM41076-0605-A).
10. The charging of the internal rechargeable battery (lithium ion battery) is carried out
exclusively with the supplied M-neb®power cord MN-300/X (type: GTM41076-
0605-A).
11. During the use of the M-neb®dose+mesh nebulizer MN-300/8, check the proper
function of the nebulizer.
12. Do not operate the M-neb®dose+mesh nebulizer MN-300/8 when damage or
defects to the M-neb®power cord MN-300/X (type: GTM41076-0605-A) are visible.
13. Medical electrical devices are subject to specific precautions with regard to
electromagnetic compatibility (EMC) and must be installed and used in accordance
with the remarks contained in these instructions for use for electromagnetic
compatibility.
14. The USB connection of the M-neb®dose+mesh nebulizer MN-300/8 (control unit) is
only used for the connection to the M-neb®dose+nebulizer unit MN-300/8. Do not
use any other commercially available USB cable with the USB connection of the M-
neb®dose+mesh nebulizer MN-300/8 (control unit) (REF: 20100262).
CAUTION
1. Do not touch the aerosol generators in the M-neb®dose+nebulizer unit MN-300/8
(with the M-neb®dose+mouthpiece MN-300/8).
2. Never insert objects into the M-neb®dose+nebulizer unit MN-300/8 (with the M-
neb®dose+mouthpiece MN-300/8).
3. Do not operate the M-neb®dose+mesh nebulizer MN-300/8 when damage or
defects to the M-neb®power cord MN-300/X (type: GTM41076-0605-A) are visible.
4. Medical electrical devices are subject to specific precautions with regard to
electromagnetic compatibility (EMC) and must be installed and used in accordance
with the remarks contained in these instructions for use for electromagnetic
compatibility.
5. To avoid damage to the device and ensure compliance with the EMC Directive,
only the original M-neb®power cord MN-300/X (type: GTM41076-0605-A) is used.
6. The USB connection of the M-neb®dose+mesh nebulizer MN-300/8 (control unit) is
only used for the connection to the M-neb®dose+nebulizer unit MN-300/8. Do not
use any other commercially available USB cable with the USB connection of the M-
neb®dose+mesh nebulizer MN-300/8 (control unit) (REF: 20100262).

- 10 -
NOTE
1. Before the first use of the M-neb®dose+mesh nebulizer MN-300/8, please check
the delivery scope for completeness. Also, check the delivered components for
obvious, visible defects, impurities, cracks or damage. Never use the M-neb®
dose+mesh nebulizer MN-300/8 or its components if they show visual defects or
faults. In this case, contact the manufacturer or your dealer.
2. The bottom of the M-neb®dose+mesh nebulizer MN-300/8 (control unit) can heat
up during prolonged use.
3. In the triggered mode, the maximum runtime is 2 hours.
In continuous mode, the maximum runtime is 1 hour.
The maximum standby time (readiness to start the triggered mode) is 60 seconds.
If the maximum runtime in the respective mode is reached, the M-neb®dose+mesh
nebulizer MN-300/8 is switched off automatically.
4. This product falls within the scope of the act governing the sale, return and
environmentally sound disposal of electrical and electronic equipment (Waste
Electrical and Electronic Equipment Act - ElektroG) and is classified in the category
8 (medical devices without implantable and infectious products). Therefore, the
electronic components of the M-neb®dose+mesh nebulizer MN-300/8 (M-neb®
dose+mesh nebulizer MN-300/8 control unit and M-neb®power cord MN-300/X
[type: GTM41076-0605-A]) may not be disposed of in the household waste.
Disposal of these electronic components is carried out according to the local waste
disposal regulations.
The component M-neb®dose+nebulizer unit MN-300/8 (using M-neb®dose+
mouthpiece MN-300/8) can be added to the municipal waste, including separately
collected fractions, plastics according to the Waste Catalogue Ordinance (AVV)
Regulation under the disposal code 20 01 39.
5. The charging time for the internal, rechargeable battery (lithium ion battery) of the
M-neb®dose+mesh nebulizer MN-300/8 depending on the initial state is:
a) for a 80% battery capacity approx. 2 hours
b) for a 100% battery capacity approx. 3 hours
6. Only use accessories certified by the manufacturer.
7. The USB connection of the M-neb®dose+mesh nebulizer MN-300/8 (control unit) is
only used for the connection to the M-neb®dose+nebulizer unit MN-300/8. Do not
use any other commercially available USB cable with the USB connection of the M-
neb®dose+mesh nebulizer MN-300/8 (control unit) (REF: 20100262).

- 11 -
3.0 Intended use
The M-neb® dose+mesh nebulizer MN-300/8 is a medication nebulizer which is intended
to bring medication in the form of a precise dose even into the smallest air passages of the
lungs.
The M-neb®dose+mesh nebulizer MN-300/8 provides aerosol doses for inhalation using
the mouthpiece. Aerosol production is triggered by breathing through the mouthpiece
(triggered mode). The maximum length of a single aerosol production phase is 1.5 seconds
(triggered mode). The production of the aerosol dose may be affected by the duration of
the inhalation session (triggered mode).
The selection of the medication, which is used for the generation of the aerosols by the M-
neb® dose+mesh nebulizer MN-300/8, may only be made by the physician.
The selected medication must be approved for this type of application (inhalation on the
principle of mesh nebulisation) by the (pharmaceutical) manufacturers.
3.1 Functional description of the M-neb®dose+mesh nebulizer MN-300/8
The M-neb® dose+mesh nebulizer MN-300/8 has two modes of nebulisation (triggered
mode and continuous mode). The basic setting of the M-neb®dose+mesh nebulizer MN-
300/8 is the triggered mode.
Any aerosol production of the M-neb® dose+mesh nebulizer MN-300/8 3 is indicated by
the signalling of the blue LED of the operating mode status indicator as well as the blue
lighting up of the M-neb®dose+nebulizer unit MN-300/8 (with the M-neb®dose+
mouthpiece MN-300/8).
3.2 Nebulizer modes
The respective nebulisation modes of the device M-neb®dose+mesh nebulizer MN-300/8
are explained in this chapter.
3.2.1 Triggered mode
In the triggered mode, the aerosol production is triggered by breathing through the
mouthpiece. The M-neb®dose+mesh nebulizer MN-300/8 only produces aerosol during
the inhalation phase (synchronisation).
In the triggered mode, the operating mode status display LED and the nebulizer unit light
up for the duration of the inhalation with each phase of the aerosol production.
The maximum duration of an aerosol production phase is 1.5 seconds.
The production of the aerosol dose may be affected by the duration of the inhalation
session.
The triggered mode is set as the default at the factory for the M-neb®dose+mesh nebulizer
MN-300/8 device.

- 12 -
3.2.2 Continuous mode
In continuous mode, the device produces aerosol continuously. In continuous mode, the
blue LEDs of the operating mode status indicator and the nebulizer unit light up
continuously for the duration of the aerosol production time.
The continuous mode is available in the M-neb®dose+mesh nebulizer MN-300/8 device.
The continuous mode must be selected in the M-neb®dose+mesh nebulizer MN-300/8
device. You can find out more on how the continuous mode is selected in the following
chapter „6.5 Changing the operating modes“.
3.3 Automatic switch-off
Regardless of the nebulisation mode, the M-neb®dose+mesh nebulizer MN-300/8
switches off automatically once the filled medication has been completely aerosolised.
Each nebulisation mode is equipped with the automatic switch off.
3.4 Maximum runtimes:
In the triggered mode, the maximum runtime is 2 hours.
In continuous mode, the maximum runtime is 1 hour.
The maximum standby time (readiness to start the triggered mode) is 60 seconds.
If the maximum runtime is reached in the respective mode, the M-neb®dose+mesh
nebulizer MN-300/8 is switched off automatically.

- 13 -
4.0 Delivery scope of the M-neb®dose+mesh nebulizer MN-300/8
The following components belong to your M-neb®dose+mesh nebulizer MN-300/8 delivery
scope:
Quantity
Number
Designation
Figure
1 pc.
20100262
M-neb®dose+mesh
nebulizer MN-300/8
(control unit)
1 pc.
20100206
M-neb® power cord MN-
300/X
(type: GTM41076-0605-A)
2 pc.
20100268
M-neb®dose+nebulizer
unit MN-300/8 (incl M-
neb®dose+mouthpiece
MN-300/8)
1 pc.
20100207
M-neb®Etui MN-300/X
NOTE
Before the first use of the M-neb®dose+mesh nebulizer MN-300/8, please check the
delivery scope for completeness. Also, check the delivered components for obvious,
visible defects, impurities, cracks or damage. Never use the M-neb®dose+mesh
nebulizer MN-300/8 or its components if they show visual defects or faults. In this case,
contact the manufacturer or your dealer.

- 14 -
5.0 The most important components of your M-neb®dose+mesh nebulizer MN-
300/8
Before you use your M-neb®dose+mesh nebulizer MN-300/8 for the first time, take some
time to familiarise yourself with the device and the accessories.
All components of the M-neb®dose+mesh nebulizer MN-300/8 are listed in the table below.
Number
Designation
Figure
20100262
M-neb®dose+mesh nebulizer
MN-300/8
(control unit)
20100206
M-neb® power cord MN-300/X
(type: GTM41076-0605-A)
20100268
M-neb®dose+nebulizer unit
MN-300/8 (incl. M-neb®dose+
mouthpiece MN-300/8)
20100269
M-neb®dose+mouthpiece
MN-300/8
available as an option
20100207
M-neb®Etui MN-300/X

- 15 -
6.0 Start-up of the M-neb®dose+mesh nebulizer MN-300/8
6.1 Filling the M-neb®dose+nebulizer unit MN-300/8
6.1.1 Open screw cap using an 80° rotation counter clockwise then lift the cap upwards.
6.1.2 Pour medication into the medication chamber.
6.1.3 Place screw cap back on and close with an 80° rotation in clockwise direction.

- 16 -
6.2 Connect M-neb®dose+nebulizer unit MN-300/8 with the M-neb®dose+mesh
nebulizer MN-300/8 (control unit)
After this, connect the filled M-neb®dose+nebulizer unit MN-300/8 with the M-neb®
dose+mesh nebulizer MN-300/8 (control unit). To do this, connect the female USB
socket of the control unit with the male USB connector of the nebulizer unit.

- 17 -
6.3 Start medication nebulisation and carry out inhalation
6.3.1 Press (> 1 second) the on/off button of the M-neb®dose+mesh nebulizer MN-
300/8 (control unit). The M-neb®dose+mesh nebulizer MN-300/8 (control unit)
switches on automatically. As indication, you will hear a short acoustic signal tone
and the battery status indicator continuously lights up green.
6.3.2 The operational readiness of the M-neb®dose+mesh nebulizer MN-300/8 is
established after the operating mode status indicator has flashed three times blue
briefly.
6.3.3 The M-neb®dose+mesh nebulizer MN-300/8 can now monitor your inhalation and
produce inspiration-triggered aerosol delivery. This aerosol is then available for
inhalation with every single breath. To do this, close your mouth around the
mouthpiece of the M-neb®flow mesh nebulizer MN-300/3 and inhale through your
mouth. (Use a nose clip for an inhalation session, if needed.)

- 18 -
6.3.4 While you carry out an inhalation session usingthe mouthpiece, the operating mode
status display LED and the nebulizer unit light up blue for the duration of the
inhalation with each phase of the aerosol production. Please note that the maximum
duration of an aerosol production phase is 1.5 seconds.
6.3.5 Do not exhale through the mouthpiece of the M-neb®dose+mesh nebulizer MN-
300/8. Put it down to exhale.
6.3.6 In order to carry out the next inhalation, close your mouth around the mouthpiece of
the M-neb®dose+mesh nebulizer MN-300/8 3 again and inhale through your mouth.
To exhale, put down the mouthpiece of the M-neb®dose+mesh nebulizer MN-300/8
again and do not exhale through the mouthpiece.
6.3.7 Repeat this procedure until the filled medication has been completely aerosolised
by the M-neb®dose+mesh nebulizer MN-300/8. The M-neb®dose+mesh nebulizer
MN-300/8 then switches off automatically.
NOTE
At every stage of the aerosol production, the operating mode status indicator and the
nebulizer unit for aerosol production will light up blue for the duration.
In the triggered mode, the maximum duration of an aerosol production phase is 1.5
seconds.

- 19 -
6.4 Switch off M-neb®dose+mesh nebulizer MN-300/8
In order to stop or pause the nebulizer before it is finished, the M-neb®dose+mesh
nebulizer MN-300/8 must be switched off. Press (> 1 second) the on/off button of the M-
neb®dose+mesh nebulizer MN-300/8 (control unit). The M-neb®dose+mesh nebulizer
MN-300/8 switches off automatically. As indication, you will hear a short acoustic signal
tone and the battery status indicator goes off.

- 20 -
6.5 Changing the operating modes
The basic setting of the M-neb®dose+mesh nebulizer MN-300/8 is the triggered mode. If
you have switched on the M-neb®dose+mesh nebulizer MN-300/8 and the operational
readiness is established, the M-neb®dose+mesh nebulizer MN-300/8 is in triggered mode.
The change of the operating modes is described below if the operational readiness of the
M-neb®dose+mesh nebulizer MN-300/8 is not established and the device is in the
switched off state.
6.5.1 Press (> 1 second) the on/off button of the M-neb®dose+mesh nebulizer MN-300/8
(control unit). The M-neb®dose+mesh nebulizer MN-300/8 switches on
automatically. As indication, you will hear a short acoustic signal toneand the battery
status indicator continuously lights up green.
6.5.2 The operational readiness of the M-neb®dose+mesh nebulizer MN-300/8 is
established after the operating mode status indicator has flashed three times blue
briefly.