Mediblink Panda M460 User manual

SLO
MEDIBLINK Kompresorski inhalator Panda M460
NAVODILA ZA UPORABO
Prosimo, da pred uporabo izdelka v celoti preberete navodila za uporabo
HRV
MEDIBLINK Kompresorski inhalator Panda M460
UPUTSTVA ZA UPOTREBU
Uputstva su vrlo važna, stoga ih sačuvajte za buduću upotrebu
EN
MEDIBLINK Compressor nebulizer Panda M460
INSTRUCTIONS FOR USE
These instructions are important
Please keep them for future reference

EN
Introduction 5
Accessories 6
Device Components 7
General warnings 8
VixOne®nebuliser cup 10
2 Masks: for adults and children 12
Mouthpiece 12
Preparing and using the appliance 12
Cleaning and maintaining 13
Checking and replacing lters 14
Technical specications 14
EMC tables 15
Legend of symbols 19
Conditions for storage and transportation 19
Environmental conditions during use 19
Warranty 20
2

SLO
Uvod 22
Dodatki 23
Sestavni deli inhalatorja 24
Splošna opozorila 25
VixOne® posodica za ziološko raztopino 27
2 maski: za dojenčke/otroke in za odrasle 29
Ustni nastavek 29
Priprava in uporaba naprave 29
Čiščenje in vzdrževanje 30
Preverjanje in menjava ltrov 31
Tehnični podatki 32
Elektromagnetna odpornost na motnje – EMC tabele 33
Legenda simbolov 37
Pogoji za shranjevanje in prevažanje 37
Okoljski pogoji za uporabo 37
Garancijski pogoji 38
3

HRV
Uvod 40
Pribor 41
Dijelovi uređaja 42
Važna upozorenja 43
Posudica za lijek na tri razine 45
2 maske: za djecu i za odrasle 47
Nastavak za usta 47
Priprema i upotreba otopine za inhalaciju 47
Čišćenje i održavanje 48
Provjera i zamjena ltera 48
Tehnički podatci 49
EMC tablice 51
Simboli 54
Uvjeti čuvanja i transporta 54
Radni uvjeti pri upotrebi uređaja 54
Jamstvo 55
4

Introduction
Dear customer,
Thank you for choosing Mediblink PANDA M460 nebulizer, a piston aerosol therapy
unit designed and manufactured according the most up-to-date technologies.
Mediblink PANDA M460 is a class IIa medical device which converts medicines
from liquid or suspension form to aerosol form, so they can be administered directly
to the airways.
Mediblink PANDA M460 nebulizer allows for deeper penetration of the medicine in
the respiratory tract, ensured by the perfect size of the aerosol particles.
Warning!
This product must be assembled, maintained and handled by an adult. Never leave
children alone during use: the unit contains small parts that could be swallowed.
This product must remain in place for use only for the time strictly needed. Once
treatment has been completed, the unit must be stored in a safe place out of reach
of children. Before using the appliance, we highly recommend that you read the
short list of warnings contained in this manual, to make sure you have correctly
understood how to use it.
EN
5

A – Adult mask
B – Children & Baby mask
C – Mouthpiece
D – Nebulizer cup
E – Connection tube
F – Filters
Accessories
EN
Picture 1: Nebulizer Accessories
A
C
E
B
D
F
6

G – Power Switch
H – Tube Connector
I – Filter & Cover
J – Nebulizer cup holder
K – Handle
L – Air Openings
M – Electric Flex
Device Components
EN
Picture 2: Nebulizer Components
H
M
I
J
L
K
G
7

1. Before use, carefully read the information in this manual, and keep for future
reference.
2. Unit designed for aerosol therapy. Follow the instructions of a medical
practitioner as to the type of medicine to use, the dose, frequency and duration
of inhalations. Any use other than the one for which the unit is intended is
considered improper and therefore dangerous; Mediblink cannot be held liable
for any damage caused by incorrect or unreasonable use or if the device is
used in electrical systems that do not conform to safety regulations in e󰀨ect.
3. A power outage, a sudden failure or any other adverse condition may cause
the unit to stop working, therefore it is recommended that users have an
alternative unit or medicine (agreed upon with a physician) that can be used in
the event this occurs.
4. After removing the appliance from its packaging, check that it is intact, without
any visible damage that may have occurred during transport. If in doubt, do not
use the appliance, and contact the Mediblink representative company in your
country.
5. Packaging (bags, box, etc.) may be dangerous and should be kept out of reach
of children.
6. Before connecting the appliance, check that your mains voltage corresponds to
that shown on the rating label. The rating label is located on the bottom of the
appliance.
7. In case of incompatibility between the appliance plug and the electrical socket,
use certied adapters if the existing legislation in the individual country allows
for it or have an Mediblink authorised technician replace the plug.
8. To ensure correct operation, make sure that the air lter is dry.
9. Do not use the appliance in the presence of nitrous oxide, oxygen or
ammable air/anaesthetic mixtures.
10. Turn o󰀨 the appliance and disconnect from the mains after use and before
adding more medicine. Do not exceed the maximum level shown on the
nebuliser cup when lling.
11. Keep the appliance and power cord away from hot surfaces.
12. Do not use the appliance while having a bath or shower, or when in a damp
place, or close to bath-tubs, sinks, washbasins, or in any other situation in
which there are liquids that may come into contact with the appliance.
13. Never touch the appliance with wet or damp hands.
14. Do not drop or put the device into water or other liquids. Should this occur,
unplug it immediately, stop using the appliance and consult a qualied
technician.
15. Do not block the openings for cooling air.
General warnings
EN
8

16. Do not use the device if you feel drowsy.
17. If children or persons with physical or mental disabilities use the appliance,
proper supervision is required. Children must be kept under adult supervision
to ensure that they do not play with the appliance. The appliance contains
small parts that can be swallowed and the power cord poses risk of strangling.
18. Do not use connectors or accessories not recommended by the manufacturer.
19. Make sure the appliance is placed on a level, stable surface when used in
order to prevent spillage.
20. During use, the surface must be free of any objects that may obstruct the
correct ow of air.
21. Use the appliance only in vertical position.
22. Never leave the appliance plugged in when it is not in use or when it is
unattended.
23. Before cleaning or performing any maintenance work on the appliance,
disconnect it from the mains by pulling the plug out of the electrical socket.
24. If you decide to no longer use the appliance, disconnect from the mains and
cut o󰀨 the power cord so the appliance cannot work. Dispose of the appliance
and power cord in compliance with existing laws. We also recommend
eliminating any parts that are potential hazards, particularly for children.
25. Refer to laws in force for information regarding the disposal of accessories
subject to wear. To dispose of the appliance, refer to Directive 2012/19/EU.
26. Do not use the appliance if, after a fall, it shows signs of damage on any of
its parts. If in doubt, do not use the device, and contact the your country‘s
Mediblink representative company Service Centre.
27. In the case of failure or malfunction of the appliance, switch it o󰀨 by removing
the plug from the mains and contact the Mediblink representative Service
Centre. Do not attempt to open, repair or tamper with the appliance.
General warnings
EN
9

The e󰀨ectiveness of aerosol therapy depends on the quality of medicine di󰀨usion
through the respiratory tract. The nebuliser cup plays an essential role in creating
particles with a diameter that is optimal for therapy, ensuring fast and uniform
treatment.
Mediblink VixOne® nebulizer cup produces particles as small as 2,3 μm (MMAD),
so approximately 90,2% of particles achieves lower airways, all the way to lungs
alveoli (PORR).
VixOne®nebuliser cup
EN
10

Picture 3a: Nebulizer cup parts
Nebulizer cup cover
Blue insert
Nebulizer medicine cup
Picture 3b: Assembling the nebulizer cup
1. 2. 3.
VixOne®nebulizer cup
EN
11

Soft masks which adapts to your face, minimising drug waste. The masks were
designed to ensure correct and e󰀩cient therapy for children and adults alike.
Adults should breath throug the mouth, as this is the most e󰀩cient way to deliver
the ow of solution directly into the lower airways, while the children mask should
cover both nose and mouth – this is due to the fact that children are not yet able to
coordinate their breathing.
The mouthpiece can be used alone, without the mask. The mouthpiece conveys
the aerosol jet directly into raspiratory tract. This minimises drug waste while
maximising e󰀩cacy.
1. Take the appliance out of the package;
2. Insert the medicine and/or saline solution in the nebuliser cup, according to the
doses recommended by your physician, without exceeding the maximum level;
3. Close the nebuliser cup and take the tube and attach it to the compressed air
outlet on the nebulizer;
4. Connect the tube to the nebuliser cup;
5. Connect the nebuliser cup to the accessory needed for the therapy: mask for
adults and children, or mouthpiece. In case of doubt, ask your physician about
which accessory to use.
6. Connect the power cord plug to the mains;
7. Turn on by pressing the on/o󰀨 switch and start therapy;
8. Start with nebulization.
9. Carry out treatment preferably seated and in a comfortable position;
10. When the aerosol jet becomes intermittent, interrupt the treatment for a few
seconds to allow the suspended drops of solution to fall on the nebuliser cup
walls. Resume the treatment session, which will be nished when no more
nebulised solution is released from the nebuliser cup;
11. Once the treatment session is completed, switch the appliance o󰀨, unplug
it, remove the accessory used and clean the appliance and accessories
according to the instructions in the Cleaning and Maintenance paragraph.
2 Masks: for adults and children
Mouthpiece
Preparing and using the appliance
EN
12

Warning!
Do not wet the device or put it into water or other liquids. For cleaning, use a clean,
dry cloth only.
After each use, remove and detach all the nebulizer components and separately
ush each part (except connection tube) of the nebulizer under running water.
Water temperature must not exceed 50 °C. Allow all nebulizer parts to air-dry
thoroughly.
Do not clean the connection tube (air tube). If the water droplets accidentally enter
the air tube, and the natural wind can not dry the air tube, then only air tube must
be connected to the nebulizer, and the nebulizer must be switched on to discharge
the water droplets from the air tube. When no droplets are left in the air tube, the
nebulizer cup and mask can be attached on the tube, and the user can start using
the nebulizer.
Warning!
Cold disinfect all parts that come in contact with the patient using denatured
alcohol. Carefully dry all components and the device before reassembling. Store in
a cool, dry place, away from light and heat.
Warning!
Never use benzene, thinners or other inammable chemical substances for
cleaning.
For increased hygienic safety, never use the same accessories on more than one
patient. Contact local Mediblink representative to order nebulizer spare parts.
Cleaning and maintenance of the compressor nebulizer
Cleaning and maintenance of the nebuliser cup and accessories
Cleaning and maintenance
EN
13

Periodically check the condition of the lter. The lter was inserted to protect the
compressor. Correct lter maintenance prolongs the life of the nebulizer. The frequency
with which lter should be replaced depends on the conditions in which the unit is used.
The lter is located on the front of the nebulizer.
To replace the lter:
1. Open the lter cover cap;
2. Remove the lter to be replaced from its housing;
3. Carefully t the new lter;
4. Fit the lter cover cap back on.
Warning!
Never leave the lter cover cap and/or lters unattended: These are small parts
posing the risk of su󰀨ocation if swallowed by children.
Checking and replacing lters
Nominal voltage: 230 V
Frequency: 50 Hz
Power: < 180 VA
Fuse: F 5 AT 250 V
Maximum ow: 17 ± 2 l/min
Operational ow: 8 ~ 9 l/min
Max pressure: > 29 Psi
Operational pressure: 10 ~ 16 Psi
Protection against liquid seepage: IP21
Weight: 1,66 kg
Dimension (L x W x H): 237,6 × 189,8 × 129,6 mm
Conditions for using the device: 30' ON – 30' OFF
MMAD: – aerosol size: 2,3 μm
PORR (Breathable fraction;
aerosol % smaller then 5 μm): 90,2 % ± 1,2 %
Nebuliser cup capacity MAX 8 ml
Noise level at 1 m: < 60 dB
Nebulization rate: 0,2 ~ 0,3 ml/min
Medicine leftover: < 1 ml
Medical device classication: IIb
Technical specications
EN
14

EN
Guidance and manufacturer’s declaration – electromagnetic emissions
The Mediblink Panda Nebulizer M460 (TCN-02WM) is intended for use in the electromagnetic
environment specied below. The customer or the user of the TCN-02WM should assure that it is
used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The TCN-02WM 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 TCN-02WM is suitable for use in all establishments
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
uctuations/icker
emissions
IEC 61000-3-3
Complies
EMC tables
15

Guidance and manufacturer’s declaration – electromagnetic immunity
The TCN-02WM is intended for use in the electromagnetic environment specied below. The
customer or the user of the TCN-02WM 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
±6kV Contact
±8kV Air
Floors should be wood, concrete
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be
at least 30 %. If ESD interfere
with the operation of equipment,
counter measurements such as
wrist strap, grounding shall be
considered.
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.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1kV differential
mode
±2kV common
mode
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 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5% UT for
0.5 cycle
40% UT for
5 cycles
70% UT for
25 cycles
<5% UT for
5 s
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the TCN-02WM requires
continued operation during
power mains interruptions,
it is recommended that the
TCN-02WM be powered from
an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic
elds should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
EMC tables
EN
16

EN
EMC tables
Guidance and manufacturer’s declaration – electromagnetic immunity – for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The TCN-02WM is intended for use in the electromagnetic environment specied below. The
customer or the user of the TCN-02WM 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
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2,5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the TCN-02WM , including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHZ
d = 2,3 800 MHz to 2,5 Ghz
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 xed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
17

Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM – for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between Portable and mobile RF communications
equipment and the TCN-02WM
The TCN-02WM is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the TCN-02WM can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the TCN-02WM as recommended below, according
to the maximum output power of the communications equipment.
Rated
maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
50 kHz
to 80 MHZ
d = 1,2
80 MHz
to 800 MHZ
d = 1,2
800 MHz to 2,5 GHz
d = 1,2
0.01 0,12 0,12 0,23
0.1 0,38 0,38 0,73
11,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
EMC tables
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reection from structures, objects and people.
EN
18

EN
Caution!
Consult the instructions for use
Electronic instructions for use:
http://www.mediblink.com/f/m460.pdf
Double insulation
Keep dry (the appliance is not
provided with specic protection
against the penetration of liquids)
Device with Type BF applied part
Complies with directive
MDD 93/42/EEC + 2007/47/EC
Alternate current
Relative humidity: 30 % / 75 %
Store in a cool, dry place.
Temperature: -10 °C / +55 °C
Product ID number
Medical device Class IIa
LOT number*
Serial Number
1639
Complies with directive
MDD 93/42/EEC + 2007/47/EC
Number of products in one packaging
Some electrical and electrical
equipment forbid to abandon and
disposal at will
Manufacturer
European Union Representative
Conditions for storage and transportation
Legend of symbols
This product complies with directive 2012/19/EU.
The crossed bin symbol on the appliance indicates that the product, at the
end of its life, must be disposed of separately from domestic waste, either
by taking it to a separate waste disposal site for electric and electronic
appliances or by returning it to your dealer when you buy another similar
appliance. The user is responsible for taking the appliance to a special waste
disposal site at the end of its life. If the disused appliance is collected correctly
as separate waste, it can be recycled, treated and disposed of ecologically;
this avoids a negative impact on both the environment and health, and
contributes towards the recycling of the product’s materials. For further
information regarding the waste disposal services available, contact your local
waste disposal agency or the shop where you bought the appliance.
Relative humidity: 45 % / 75 % Temperature: -10 °C / +40 °C
Environmental conditions during use
*Date of manufacture: rst pair of LOT numbers presents the month of manufacture, the second pair of
numbers presents the year of production. Example: LOT 1025 = October, 2025.
19

WARRANTY TERMS
Dear customers!
The warranty period is 10 years and starts from the day of product purchase. The
warranty period on spare parts: masks, mouthpiece, tube and lters is 1 year. In case of
product claim, you have to show the invoice. We kindly ask you to save the invoice!
Unfortunately, wrong handling with the device is a reason for 95% of customer
complains. You can easily avoid any problem, by getting useful information provided
by our special service department. To reach our service department, you can call or
send e-mail to Mediblink local distributor.
Before sending the product back to retailer, we kindly ask you to call our service
department, to get help about how to use the device to save you with unneeded trips.
The manufacturer guarantees free elimination of all imperfections due to defects in
material or manufacturing procedure by repairing or replacing the product. In case that
the product can not be repaired or replaced, the customer will get the money refund.
The guarantee is not valid in case of the force majeure, accidents or unexpected
events (such as lightning, water, re etc.), incorrect use or incorrect transport, non-
compliance with safety and maintaining regulations or in case of unprofessional
product intervention.
Traces of every day product usage (scratches, abrasions) and not subject to claim.
The warranty does not eliminate the customer rights, which originate from seller
responsibility for product aws. By accepting the claimed product by the service
department, the service department does not take responsibility for loss of saved data
or settings on the product. All product repairs, which are performed out of product
warranty period, have to be paid by customer by prior notice.
The manufacturer guarantees the product quality and awless product operation in the
warranty period, which starts with the day of product purchase. If the product can not
be repaired in 45 days, the product will be replaced with a new one. In case that the
product can not be replaced, the money will be refunded to the customer.
In case of product claim, call or send e-mail to Mediblink local distributor.
Any serious incident that has occurred in relation to the device should be reported to
the manufacturer (Dongguan Topwell Medical Devices Company Limited), company
Mediblink d.o.o. and the competent authority of the Member State in which the user
and/or patient is established.
Warranty
EN
Product: Mediblink Compressor Nebulizer Panda M460
Manufactured for (also EU importer): Mediblink d.o.o., Gubčeva cesta 19,
8210 Trebnje, Slovenia; [email protected]; www.mediblink.com
Sellers name, address, signature and stamp*:
Date of extradition/sales*:
*If the invoice is accompanied by this warranty, and if all above information can be seen from the invoice, it is not necessary to ll in this eld.
20