MedNet YM-3R9 User manual

INSTRUCTIONS FOR USE
Portable mesh nebulizer
YM-3R9
Doc No: YMDK/RD-CE-YMRX--
Rev. No: V1.0
Issue date: 24.06.2020
Software version No: V1.0
Modification date: 24.06.2020

INSTRUCTIONS FOR USE
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TABLE OF CONTENTS
Introduction ........................................................................................................
Chapter  Safety instructions and symbols.....................................................
. General comments about safety.................................................................. 
. Warning..........................................................................................................
. Symbols .........................................................................................................
Chapter  Product information ......................................................................... 
. Components ..................................................................................................
. Intended use/user.........................................................................................
. Contraindications for use:.............................................................................
. Component names and functions................................................................
Chapter  Nebulizer installation .......................................................................
. Cleaning before use ...................................................................................... 
. Assembling the medicine cup......................................................................
. Inserting the battery or connecting to the power adapter.......................
... Battery power supply.......................................................................
... Connecting to the power adapter....................................................
. Component assembly.................................................................................
... Attach the mask ...............................................................................
... Attach the mouthpiece ....................................................................
Chapter  Filling with medication ..................................................................
. Pour the medication into the medicine cup:.............................................
Chapter  Operating the nebulizer.................................................................
. Inhalation.....................................................................................................
Chapter  Replacing the medicine cup..........................................................
Chapter  Power Supply ..................................................................................
. Inserting the batteries................................................................................
. Operation using a mains adapter...............................................................
Chapter  Cleaning and disinfection ..............................................................
Chapter  Technical specification....................................................................
Chapter  Product characteristics.................................................................
Chapter  Troubleshooting............................................................................
Chapter  EMC Declaration ............................................................................
WARRANTY CARD ..............................................................................................

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Introduction
Copyrights
©Shenzhen IMDK Medical Technology Co., Ltd. All rights reserved.
Note
For copyright reasons, no part of these instructions may be photocopied,
reproduced or translated into another language without the priorwritten
consent of IMDK.
Manufacturer’s responsibility
IMDK is only responsible for the safety, reliability and performance of
the equipment if:
Installation, extensions, initial modifications and repairs are carried out
by personnel approved by IMDK and the electrical installation at the
site complies with the relevant standards. The equipment is used in
accordance with the instructions for use. At the user’s request, IMDK will
provide technical documentation or diagrams to enable the company’s
accredited service technicians to maintain and repair the equipment.
Warranty
The user must not carry out any repairs to this device. All repairs should
be carried out by an authorised service centre. The warranty for this unit
covers damage caused by defects in the unit itself or in the manufac-
turing process. Any damaged parts will be repaired or replaced free of
charge during the warranty period. Damage caused by the user is not
covered by the warranty.
Chapter 1 Safety instructions and symbols
1.1 General comments about safety
The device has an internal power source and its shock protection class is
BF. Carefully inspect the nebulizer (hereinafter referred to as the device)
and its accessories to ensure that there are no visible defects that could
affect patient safety and device performance. It is advisable to carry out
such a check before each use.
Observe the WARNINGS and CAUTIONS to avoid possible injury.

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Notes:
1. Read these instructions carefully before use and operate the
device in accordance with them.
2. Keep these instructions in a safe place for future reference.
3. For hygienic reasons, the nebulizer and its accessories are in-
tended for use by one patient. However, the device is intended for
use by more than one patient.
1.2 Warning
Warning: Followyour doctor’s instructions about the type, dose and
use of your medicine.
Warning: Use inhalation solutions prescribed by your doctor.
Warning: This device is for personal use. Do not share the device
with other people.
Warning: When using the nebulizer for the first time or if it has not
been used for a long time, clean the parts before use.
Warning: After each use, rinse the medicine cup, the lid of the med-
icine cup, the mask and the mouthpiece with distilled water. The
rinsed parts should be dried immediately.
Warning: Before using the mask connecting tube and the mask itself
for the first time, rinse them with cleanwater and dry. The accessories
may be reused after washing and drying.
Warning: This product will only be repaired by an authorised, qualified
service centre. If the user requires service/maintenance information,
please contact the company by telephone: [phone].
Warning: The device is supplied with a USB cable. When using a
mains adapter, ensure that it complies with IEC60601-1 IEC60601-1-11
(standards specific to medical power supplies).
Warning: Do not use any parts other than those specified in the
instructions.
Warning: Do not use any removable parts that are not specified in
the instructions for use.
Warning: Do not make any modifications to the device.
Warning: Keep the device away from active high frequency surgical
equipment and the RF shielded room of an ME system for magnetic

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resonance imaging, where the intensity of electromagnetic distur -
bance is high.
Warning: Do not use the device near or on other equipment as this
may cause it to malfunction. If such use is necessary, observe both
devices to check that they are working properly.
Warning: The use of accessories, converters and cables other than
those specified or supplied by the manufacturer of this device may
increase electromagnetic emissions or reduce the electromagnetic
immunity of this device and cause it to malfunction.
Warning: Portable RF communication devices (including peripheral
devices such as antenna cables and external antennas) should be
used no closer than 30 cm from any part of the nebulizer, including
cables specified by the manufacturer. Failure to do so may result in
reduced performance of this equipment.
Otherwise, the performance of this equipment may be degraded.
In the above case: the device may stop working properly or dete-
riorate due to electromagnetic interference.
To avoid possible injury, the device should only be used within its shelf
life. The shelf life of this product is 3 years, the date of manufacture can
be found on the product label. Always follow the instructions when
using the device.
CAUTION: Do not hit the device as this may damage it and affect
its operation.
CAUTION: Do not touch the medicine cup and mesh with a cotton
pad or other object as this may render the component unusable.
CAUTION: Clean the device after each use, otherwise the nebulizer
may not work properly.
CAUTION: If the nebulizer does not switch off automatically when
the medication has been used up, press the switch immediately to
avoid tearing the spray mesh.
CAUTION: Use distilled water to clean the device.
CAUTION: Do not immerse the device or its power supply in water.
CAUTION: Do not drop the nebulizer.

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CAUTION: If there is liquid in the medicine cup, do not tilt it to prevent
liquid spillage.
CAUTION: After use, do not leave the device in a place accessible to
children or the mentally ill.
CAUTION: Children and the mentally ill should use the device under
adult supervision.
CAUTION: If the batteryis not going to be used for more than a week,
remove it from the device.
CAUTION: At the end of its life, the device should be recycled in
accordance with local legislation.
CAUTION: Dispose of used batteries, mouthpieces, masks, connecting
tubes, etc. in accordance with local environmental regulations. Dispose
of used device and accessories in accordance with local regulations.
CAUTION: Do not expose the nebulizer to direct sunlight or dust as
this may adversely affect the volume and rate of atomisation.
1.3 Symbols
Symbol Explanation
BF type application part
Instructions for use
Caution
Selective waste collection
Keep dry
“ON/OFF" button
IP22 Waterproofing grade
CE mark
Serial number
Date of manufacture

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Symbol Explanation
Manufacturer
Read the instructions for use
European Authorized Representative
Environmentally friendly lifespan
Do not reuse
Non-sterile
Medical device does not contain "DEHP"
Warning
Importer
Unique device Identifier
Chapter 2 Product information
2.1 Components
Portable mesh nebulizerkits consist of a main unit, medicine cup, children’s
mask, adult mask, mouthpiece, mask connecting tube and head cover.
Main unit Medicine cup
(spraying head)
Children’s mask Adult mask

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Mouthpiece Mask connecting
tube
Head cover Batteries: two AA
(1,5 V) alkaline
batteries
Accessories
Accessories for the device are listed in the table below.
Name Model/specification Quantity
Micro USB cable USB-DC3.5-1.5M 1
Portable mesh nebulizer kit F224R*E001 1
Batteries AA 
The portable mesh nebulizer kit contains the following components:
Part name Material Part No Quantity
Medicine cup PC 110 Y299R*A001 1
Children’s mask PVC Y298R*A901 1
Adult mask PVC Y297R*A901 1
Mouthpiece Silica gel HT-8150 Y272R*G10 1
Mask connecting tube PC 110 Y268R*A901 1
Head cover Silicone not applicable 1
2.2 Intended use/user
Intended use:

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The portable mesh nebulizer is designed for the inhalation of aerosol
medication by adults or children. The device can be used by patients
with asthma. There are no medical contraindications.
Target user group:
Adults, adolescents and children between 4 and 11 years old.
The MEDICAL DEVICE is suitable for home use.
2.3 Contraindications for use:
This device is not suitable for use with oily medicines. The device is
not suitable for use with suspensions or highly viscous medicines (e.g.
Nebu-Dose Hyaluronic).
This device is not intended for use as an anaesthetic or lung ventilator.
In such cases, information should be obtained from the manufacturer
of the medicine.
2.4 Component names and functions
2
3
4
1
Rear view
1. Medicine cup lid
2. Medicine cup
3. PUSH – Release button. Press to
remove the medicine cup.
4. DC input: connect suitable DC
jack (DC 5 V)

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5
6
7
8
9
10
11
Front view
5. Close the battery cover after
inserting the battery.
6. When inserting the batteries,
observe the +/- markings (bat-
teries included).
7. ON/OFF button: Press the ON/OFF
button to turn the device on.
8. Power indicator:
• The green light is on: Ongoing
operation
• The red light is on/flashing:
Low power/malfunction
• No light: Malfunction
9. Medicine cup connecting
tube: Connect it directly to the
mouthpiece
10. Spray mesh
11. Mask connecting tube (it can be
removed)
To avoid cross-contamination, each user should have their own set of
net nebulizer accessories. Additional accessories must be purchased
from your dealer or product manufacturer.
The device works with 2 AA alkaline batteries or by using a mains
adapter.
Mains adapter specifications: input: 100–240 V AC 50/60 Hz
output: 5 V DC, the users buys it from
a qualified manufacturer.

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Chapter 3 Nebulizer installation
3.1 Cleaning before use
Rinse and then dry the relevant nebulizer components before use.
3.2 Assembling the medicine cup
Insert the medicine cup into the main unit so that the three tabs on the
back of the medicine cup fit into the three recesses on the main unit. If
this adjustment is correct, you will hear a“click” sound.
Instructions for assembling the med-
icine cup:
•
Make sure that the medication
cup is fitted correctly, otherwise
the nebulizer may not connect and
operate correctly.
• Keep the main unit and medicine
cup clean to prevent the nebulizer
from malfunctioning.
Instructions for disassembling the
medicine cup:
• Press down on the medicine cup
while pressing the button so as not
to damage the nebulizer.
• Do not touch the spray mesh with
your fingers or other objects during
disassembly to avoid damaging it.

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3.3 Inserting the battery or connecting to the power adapter
CAUTION: It is not possible to use the battery and the power adapter
at the same time!
3.3.1. Battery power supply
1. Open the
battery cover.
2. Insert the two
batteries, taking
care to match the
poles.
3. Close the
battery
cover.
3.3.2. Connecting to the power adapter
• Remove the DC input cover.
• Plug the cable into the USB power socket on the main unit.
• Plug the power adapter into a standard socket. The power adapter is
an optional accessory and is not included in the kit.
DC input cover

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3.4 Component assembly:
3.4.1. Attach the mask:
3.4.2. Attach the mouthpiece (installation directly onto the medicine
cup connecting tube)

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Chapter 4 Filling with medication
4.1 Pour the medication into the medicine cup:
• Open the medicine cup cover.
• Fill the medicine cup with the medicine prescribed by your doctor.
• The nebulizer has been tested with medicines such as Ventolin and
Pulmicort.
• The maximum capacity of the medicine cup is 8 ml.
• Close the cover of the medicine cup properly.
Warning:
• If the medication solution runs out, tilt the device slightly to ensure
that all the medication is used up.
• Suspensions or highlyviscous medicines are not suitable for this device.
• If sediment builds up on the mesh, nebulization may stop. If this
happens, turn off the power and use gauze or a lint-free towel to
absorb the sediment from the mesh.

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Chapter 5 Operating the nebulizer
5.1 Inhalation
• Press the ON/OFF button to switch on (the green light will come on).
• Place the mouthpiece between yourteeth and tighten your lips around it.
Press
CAUTION:
• If the battery is low, the red light will come on.
Replace the battery. We do not recommend using
rechargeable batteries.
• If there is no medication in the cup, the power
light will flash for 1–3 seconds after switching on
and then the devicewill switch off automatically.
• If the device is in room conditions and the tem-
perature is 20ºC, it can be used immediately
without waiting.
• If you are using a mask, place it over your mouth and nose.
• Continue to inhale until the aerosol production stops.
• The inhaler has two inhalation speed modes:
slower – press the ON/OFF button once,
faster – press the ON/OFF button twice.
Press the ON/OFF button a third time to switch off the inhaler.
When you have finished inhaling, remove the batteries from the main
unit to avoid discharging them.

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Chapter 6 Replacing the medicine cup
1. Remove the medicine cup from the
nebulizer: press the button PUSH on
the main device and push the medi-
cine cup towards the front of the main
device.
2. Insert the new medicine
cup into the nebulizer.
Chapter 7 Power Supply
The nebulizer can be powered by battery or an external mains adapter.
7.1 Inserting the batteries (2 AA alkaline batteries).
1. Otwórz
pokrywę
na baterie
2. Włóż 2 baterie
zwracając uwagę
na odpowiednie
ułożenie biegunów
3. Zamknij
pokrywę
na baterie
• Turn the device upside down.
• Open the battery cover.
• Insert two AAalkaline batteries as indicated in the battery compartment.
• Close the battery cover.

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CAUTION: Batteries included.
CAUTION: Battery life mayvary depending on the type of batteries used.
CAUTION: When the red light comes on (indicating low power), replace
both batteries with new ones of the same type.
7. 2 Operation using a mains adapter
7. 2 .1. See “3.3.2. Connecting to the mains adapter”, page 10
7.2.2.
Overcurrent and overvoltage protection: The nebulizer detects
an overcurrent or short circuit.
DC input (DC 5 V)
CAUTION: The company does not supplya mains adapter.
• Please use a mains adapter with a DC output voltage
of 5 V, 1 A and conforming to IEC 60601-1, provided
that there are at least two means of patient protection
(MOPP) between the AC input and the DC output.
• Unplug the mains adapter after use. Do not leave the
power cord plugged in when the nebulizer is not in use.
Chapter 8 Cleaning and disinfection
To avoid cross-contamination, each user should have their own set of
net nebulizer accessories. Accessories must be cleaned and disinfected
before use. Switch off the power supply before cleaning and disinfecting.
Detailed cleaning and disinfection procedures are described below:
1. Step one – cleaning the medicine cup
1.1 Open the medicine cup fitted to the main device.
1.2 Pour a small amount (approx. 8 ml) of hot distilled water into the
medication cup and close the cover. The water temperature should
be 30–60°C.
1.3 Press the ON/OFF button, the device will switch on and nebulize
with distilled water for 1–2 minutes.
1.4 Rinse the medicine cup, nozzle attachment and mesh with distilled
water. Gently wipe off excess water with a soft, clean cloth.

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1.5 To disinfect, immerse the medicine cup in 75% medical alcohol for
at least 3 minutes.
1.6 Remove the medicine cup, wipe off any excess alcohol with a soft,
clean cloth, and leave it to dry.
2.
Step two – cleaning and disinfecting the masks, mouthpiece and
mask connecting tube
2.1 Soak the accessories in clean water (≤50°C) for 2–3 minutes.
2.2 Dry them with medical gauze.
2.3 Wipe accessories with 75% medical alcohol for at least 3 minutes
to disinfect.
CAUTION: If the accessories are not properly cleaned and disinfected,
they may be contaminated with microorganisms that could pose a
risk of infection.
3.
Cleaning the main device (maintenance of the main frame and
cleaning after nebulization)
Clean the main device after use.
3.1 Clean the surface of the main device with a soft, clean cloth damp-
ened with 75% alcohol.
3.2 The electrodes must be cleaned for the device to function properly.
CAUTION:
• Do not wipe the main device with any other type of volatile liquid,
such as benzene or thinner.
• Do not rinse or immerse the main device in any liquid.
Chapter 9 Technical specification
Device name Portable mesh nebulizer
Model YM-3R9
Dimensions approx. 45×45×100 mm (L)×(W)×(H)
Weight (g) approx. 100 g (without batteries)

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Power supply Batteries: two AA alkaline batteries (batteries
included)
Power supply: voltage 3 V, current: 1 A;
Mains adapter: voltage 5 V, current: 1 A (not
included)
Energy consumption approx. 2.0 W
Oscillating frequency approx. 110 KHz ±10%
Nebulisation rate ≥0.2 ml/min – depending on the substance
used and the mode of inhalation speed
Permissible medicine tem-
perature
≤40°C
Noise level ≤50 dB(A) (approx. 1 m)
Respirable fraction The proportion of particles with a diameter <5
µm is greater than 50%.
Particle size (MMAD) <5 µm
Medicine cup capacity Max. 8 ml
Warranty Main device and head: 2 years
Product lifetime: Main device: 3 years; accessories: 1 year
Terms of use Temperature: 5–40°C
Humidity: ≤93% RH (non-condensing) Air
pressure: 800–1060 hPa
Storage and transport
conditions
Temperature: −20–50°C
Humidity: ≤93% RH (non-condensing)
Air pressure: 800–1060 hPa
The manufacturer reserves the right to change technical parameters
without notice.
Warning:
The optional mains adapter is compliant with the requirements of IEC
60601-1:2005. For more information, please contact your nearest point
of sale.

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Test with Pulmicort at normal temperature of 24 ±2°C, relative hu-
midity: 45–75% and pressure: 86 kPa to 106 kPa, – for details: chart 1:
Medicines used for testing:
1. For particle size determination - Budesonide (Pulmicort) solution
0.025 % (M/V).
2. For determination of aerosol initial velocity and aerosol efficiency
– Budesonide (Pulmicort) 0.05% (MV) solution.
individual test
mean value
Cumulative percentage (%)
Mean mass fraction (%)
Aerodynamic mean (µm)
Chart 1