Mediblink M480 User manual

1
SLO  MediblinkUltrazvočniinhalatorM480
NAVODILA ZA UPORABO
Prosimo, da pred uporabo izdelka v celoti preberete navodila
za uporabo
EN
MediblinkUltrasonicnebulizerM480
INSTRUCTIONS FOR USE
Please read this guidebook completely before operating this unit.
HRV MediblinkUltrazvučniinhalatorM480
UPUTE ZA UPOTREBU
Pažljivo pročitajte upute prije upotrebe uređaja

2
EN
Introduction 5
Accessories 6
Device Components 7
Warnings 8
Aerosol output of NaF 9
Symbol use 13
Instructions 14
Cleaning and maintenance 17
Filter change 17
Technical features 18
Troubleshooting 18
EMC Declaration 19
Warranty 23

3
SLO
Uvod 25
Dodatki 26
Sestavni deli inhalatorja 27
Opozorila 28
Izhod razpršila NaF 29
Uporabljeni simboli 33
Navodila 34
Čiščenje in vzdrževanje 37
Menjava ltra 37
Tehnične lastnosti 38
Odpravljanje težav 38
Izjava o elektromagnetni združljivosti 39
Garancija 43

4
HRV
Uvod 45
Pribor 46
Dijelovi uređaja 47
Upozorenja 48
Izlaz aerosola NaF 49
Upotreba simbola 53
Upute 54
Čišćenje i održavanje 57
Zamjena ltra 57
Tehnička svojstva 58
Rješavanje problema 59
Izjava o elektromagnetskoj kompatibilnosti (EMC) 59
Jamstvo 63

EN
5
Introduction
Dear Customer,
Thank you for choosing Mediblink Ultrasonic Nebulizer M480, an ultrasonic aerosol
therapy unit designed and manufactured according to the most up-to-date technologies.
Mediblink Ultrasonic Nebulizer M480 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 Ultrasonic Nebulizer M480 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.

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6
Accessories
The device includes the following parts, provided in a polyethylene envelope supplied
with the device.
Fig.2
Fig.5
Fig.6 Fi g.7
Fig.1
Fig.4
Warning! Air outlet is strictly
prohibited from entering water Indicate line for water
level in water tank
.
Fig.8 Fi g.9
1
2
3
4
5
67
12
3
5
6
78
4
Fig.3
10ml, Level for
Medicine liquid
5ml, Level for
Medicine liquid
Fig.2
Fig.5
Fig.6 Fi g.7
Fig.1
Fig.4
Warning! Air outlet is strictly
prohibited from entering water Indicate line for water
level in water tank
.
Fig.8 Fi g.9
1
2
3
4
5
67
12
3
5
6
78
4
Fig.3
10ml, Level for
Medicine liquid
5ml, Level for
Medicine liquid
No. Component Model no. Item no. Material Quantity
1 Adult mask PNEMAD 180-S08MZ7 PVC+PP 1
2 Pediatric mask PNEMIN 180-S09MZ8 PVC+PP 1
3 Medicine cup PNEBCAM3 XC-S02YB PVC 10
4 Sealed ring PNEBUANL 180-G02DQ Silicon 3
5 Extension tube PNEBTUB3 180-S06SSG1 PP 1
6 Adapter RSS1006-
180240-W2B-H 180-D02SPQ / 1
7 Mouthpiece PNEMOU 180-S01YZ PP 1
8 Nosepiece PNEBNOS 180-S08BC7 PP 1
List of Accessories
Picture 1: Nebulizer Accessories

EN
7
Device Components
Your ultrasound Mediblink M480 system for aerosol therapy.
Picture 2: Nebulizer Components
1 – Atomizing nozzle (or Blue Connector)
2 – Medicine Cup
3 – Sealed ring
4 – Sensor for water level
5 – Body of the device with water tank
6 – Switch
7 – Warning light
Fi g.2
Fi g.5
Fi g.6 Fi g.7
Fi g.1
Fi g.4
Warning! Air outlet is strictly
prohibited from entering water Indicate line for water
level in water tank
.
Fi g.8 Fi g.9
1
2
3
4
5
67
12
35
6
78
4
Fi g.3
10ml, Level for
Medicine liquid
5ml, Level for
Medicine liquid

EN
8
Warnings and precautions, operating cautions
Introduction
Intended use: The Ultrasonic Nebulizer for Conscious Patients is intended for con-
verting Albuterol Sulfate or saline solution uid into an aerosol for inhalation by adult or
pediatric patients.
Contraindication: Never use with unconscious patients.
Target user group: Legally certied medical experts, such as doctors, nurses and
therapists or healthcare personnel or patients under the guidance of qualied medical
experts for home treatment.
Themedicalconditionstobetreated: The device is intended for use in the treatment
of asthma, COPD and other respiratory ailments in which an aerosolized medication or
saline solution is required during therapy.
The lifespan of the device is 5 years.
1. Keep your eyes away from the output of medication mist. Change the water after
each use.
2. The maximum capacity of the medication cup is 10ml and it should not be
overlled.
3. Dilute dense medications or medication volumes 2ml or less with distilled water or
saline solution to obtain a volume of at least 4ml.
4. Do not use this unit while operating a vehicle.
5. If any discomfort or abnormality occurs, stop using the unit immediately.

EN
9
Warnings
1. Do not expose the Nebulizer to: high temperatures, humidity, dust or direct light.
2. Do not drop it or shock it.
3. To avoid infections and contagions, the mask, medicine cup and extension tube
must be treated as disposable.
4. Do not ll the tank above the volume specied in the manual.
5. Do not let the medicine remain in the nebulization chamber if the Nebulizer is not
in use.
6. Disconnect the Nebulizer from the electric outlet before cleaning, lling with
medicine and after each use.
7. Use the Nebulizer on an intermittent basis, i.e., after 20 minutes, discontinue use
for 40 minutes and, if necessary, return it to use for no longer than 20 minutes.
8. Never wash, soak or submerge the nebulizer in water or any other liquid. To clean
it, follow the precise instructions in the item MAINTENANCE AND CLEANING in
this manual.
9. Do not use it with wet hands, as there is a risk of damaging the nebulizer and the user.
10. Never use the unit if it has damaged parts (including the power cord), or if it has
been dropped or submerged in water. Send it immediately to technical assistance
for tests and repairs.
11. Children must not use the Nebulizer without an adult’s supervision.
12. Do not deect the nebulizer as there is a risk of medicine leakage and malfunction.
13. Please use the adult mask, a pediatric mask with a CE certicate with notied body
number.
14. The accessories are disposable products that can’t be reused. If you need to
replace them with new accessories, please contact local Mediblink distributor.
15. For hygiene reasons, each user must use their own accessories and accessories
for single-use.
Aerosol output of NaF
1. Testmethod
a) Air is used.
b) The nebulizer is lled with the tested drug (2ml NaF 1.0% (M/V) and the ow rates
are 2 L/min) for the aerosol output rate and aerosol output test.
c) The aerosol output is expressed as millilitres of NaF 1.0% (M/V).
d) The nebulizer is lled with the tested drug (2ml NaF 2.5% (M/V) and the ow rates
are 2 L/min) for the particle sizing test.

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10
Table 2: Mass fraction of the drug collected on each stage of the Marple impactor
Figure A: Plot of the cumulative size distribution of the results in table 2
Aerosol output of NaF
2. NaF (minimum speed) test results
Table 1: Summary of the test results for the proposed device (M480)

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Aerosol output of NaF
3. NaF (medium speed) test results
Table 3: Summary of the test results for the proposed device (M480)
Table 4: Mass fraction of the drug collected on each stage of the Marple impactor
Figure B: Plot of the cumulative size distribution of the results in table 4

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Aerosol output of NaF
Figure C: Plot of the cumulative size distribution of the results in table 6
4. NaF(maximumspeed)testresults
Table 5: Summary of the test results for the proposed device (M480)
Table 6: Mass fraction of the drug collected on each stage of the Marple impactor

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13
Symbol use
Symbols Meanings of Symbols
Type BF Applied Part
Class II equipment
Refer to instruction manual/ booklet
e-IFU:
http://www.mediblink.com/f/m480.pdf
Manufacturer
Date of manufacture
Authorized Representative in the
European community
Medical Device
Batch code*
Serial number
Use-by date
The marking of electrical and
electronic devices is according to
Directive 2002/96/EC. The device,
accessories and packaging must be
disposed of correctly after usage.
Please follow the Local Ordinances
or Regulations for disposal.
Symbols Meanings of Symbols
Non-sterile
Do not re-use
CE marking
Protected against solid foreign objects
of 12.5mm diameter and greater.
Number of products in one packaging
-20°C
+70°C
Storage temperature limit
÷ 95% RH
10%
Storage humidity limitation
700hPa
1060hPa Storage atmospheric pressure
limitation
This way up
Fragile, handle with care
Keep dry
Stacking limit of 6
Caution!
*Date of manufacture: the rst pair of LOT numbers presents month of manufacture, the second pair of
numbers presents the year of production. Example: LOT 1025 = October 2025.
Follow the precise use instructions contained in this manual and do not use the Nebulizer
in any way not described in this manual (such as using accessories not provided by the
manufacturer, inserting objects or opening it) at risk of accidents and loss of warranty.
Do not store the unit in direct sunlight, high temperature or humidity.
Keep the unit out of reach of small children.
Always keep the unit unplugged while not in use.
Storage Cautions
ATTENTION–Instructionsforthecorrectdisposaloftheproduct
This symbol indicates that the product must not be disposed of with domestic
waste after use, but in accordance with the legal provisions in force, in order to
avoid negative health and environmental implications.

EN
14
Instructions
1. Consult your family doctor before using this device.
2. Keep the device out of children’s reach.
3. Once the treatment is over, disconnect the device from the socket by unplugging
the adapter.
For the correct use and maintenance time of your new system for aerosol therapy, we
recommend reading the following indications carefully.
HowtouseyourM480nebulizerforaerosoltherapy
Make sure that the device and all the accessories are thoroughly clean, then proceed
consecutively with the following operations:
1. Position the device on a stable, bare at surface (table without a tablecloth or other
covering) near a power point.
2. Open the device cover.
3. Remove the upper part as shown in Fig.1.
4. Fill the tank with cold tap-water (distilled water or ltered water are not allowed,
using a small container as shown in Fig.2, to the level indicated inside the tank
(Fig.9): this water allows the conduction of ultrasound waves to the medicine and
is never nebulized.
5. Take a medicine cup with the medicine in it as shown in Fig.3.
6. Put the sealed ring on the machine around the mouth of the tank before placing
the medicine cup in.
7. Place the medicine cup with the medicine in its slot under the upper part of the
device (Fig.4), without spilling the drug from the medicine cup.
8. Place the upper part onto the body of the device by carefully joining the two parts.
9. Match the connector with the extension tube, then connect the free end of the
connector to the mask for nebulized drug emission (Fig.5), and apply the free
end of the extension tube to either of the two masks, the mouthpiece or the nasal
piece, according to the treatment required and to the mode of administration
selected.
10. Insert the current adapter into the socket on the back of the device.
11. Warning! The air outlet is strictly prohibited from entering water. Please see Fig.8.
12. Note the line for the water level in the water tank (see Fig.9); the water tank must
be used with tap-water, distilled water or ltered water are not permitted because
the sensor cannot work with them.
Nowthedeviceisreadyforuse.

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15
Instructions
Howtoperformaerosoltherapy
Fig.2
Fig.5
Fig.6 Fig.7
Fig.1
Fig.4
Warning! Air outlet is strictly
prohibited from entering water Indicate line for water
level in water tank
.
Fig.8 Fig.9
1
2
3
4
5
67
12
35
6
78
4
Fig.3
10ml, Level for
Medicine liquid
5ml, Level for
Medicine liquid

EN
16
Instructions
1. Plug the current adapter into a suitable socket (see the label on the bottom of the
device).
2. Press the switch on the top of the device: the warning light on the top lights up
(green light) indicating that the device is working.
3. During therapy, keep the device in a vertical position to allow the correct
functioning of the device, and to achieve the greatest e󰀨ectiveness.
4. The drug nebulization speed may be controlled by pressing ‘MIN’, ‘MID’ and ‘MAX’.
During child treatment, we mostly advise turning the knob to the ‘MIN’ position, in
order to help airway deposition.
5. Continue the treatment until a light mist is visible (drug nebulization generated by
the device).
6. After one treatment session, it is necessary to rell the water in the tank for the
next treatment.
Caution:normally,attheendofthetreatment,asmallamountofmedicine
remainsintheMedicineholder:thisamount,calledtheresidualvolume,cannot
be nebulized.
Once the treatment is over:
1. Switch the device o󰀨 by pressing the switch control.
2. Disconnect the current adapter from the power point.
3. Remove the current adapter from the socket on the back of the device.
4. Remove the blue connector from the nebulizer body, and the mask (or other
accessory) from the end of the extension tube.
5. Remove the blue connector from the extension tube.
6. Remove the medicine cup and sealed ring from the body of the device.
7. Remove the water from the water tank.
8. Wipe the water tank carefully with a soft cloth, and make sure that the water tank
and blue connector are completely dry.
9. Place the medicine cup, sealed ring and blue connector onto the body of the
device.
10. Place all the accessories into the box, together with the device.

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17
Cleaning and maintenance
Cautions:
Check the medication cup and air lter before each use. Dirty or worn parts should be
replaced. Do not immerse the unit in water.
It is important to clean your Ultrasonic Nebulizer before it is used for the rst time and after
each use. Remember to disconnect the unit from the electrical outlet. Never immerse the
unit in water. It may damage the unit.
Do not use any powdered cleaners or soap pads, which may damage the nish.
Cleaningthedevice
1. Disconnect the unit from the electrical outlet before cleaning.
2. The surface of the main unit should be cleaned with a soft cloth moistened with a
non-abrasive cleanser and water below 30°C. Don’t put the main unit directly into water.
The ultrasonic part can be wiped with a cotton stick with clean water below 30°C.
3. Clean the atomizing nozzle with hot water after each use and clean with a mild
detergent after the last treatment of the day.
Caution! During cleaning procedure, do not press on the ultrasonic membrane,
because it can be permanently damaged.
Filterchange
1. Do not use cotton or any other materials. Do not wash or clean the lter. Only use
lters supplied by your distributor. And do not operate without a lter.
2. Change the lter every 30 days or when it turns grey.
3. Changing procedure:
a) Remove the lter cover
b) Replace the used lter with a new one
c) Replace the lter cover
Howtopreservethee󰀨ectivenessofyourdevice
1. Your M480 ultrasound system for aerosol therapy does not require any particular
maintenance care; you only need to:
- avoid hitting or dropping it;
- avoid opening it under any circumstances;
- keep it in a suitable place, avoiding high temperatures, direct sunlight, humidity and dust;
- avoid using the device for more than 30 minutes uninterruptedly.
2. After all sessions, carefully clean all the accessories used.
Accessories may be washed under running water. If you want to sterilize them, a
cold solution suggested by your family doctor may be used.
3. We recommend performing a maximum of 2 treatments using a single medicinal
holder (cup) before replacing it.
4. We strongly recommend replacing the air lter after 15/20 treatments, or when the
lter becomes grey. For the substitution, proceed as follows:
- remove the cap from its slot under the base of the device;
- remove the old lter and introduce the new one;
- replace the cap inside its slot.

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18
Technicalfeatures
Name and model number Mediblink Ultrasonic Nebulizer M480,
Model: ULTRANEB DESK 2
Power 100–240 VAC 50/60 Hz, 0.6 A
Ultrasonic Frequency 2.4 MHz ± 50 kHz
Nebulization rate (NaF) MIN: 0.4–0.64 ml/min MED: 0.6–0.8 ml/min
MAX: 0.65–0.9 ml/min
Particle Size MMAD (NaF) 1.19-1.52 μm, depending on nebulization rate setting
Medicine Cup Capacity Approximately 10 ml maximum
Noise level 32,9 dB
Dimensions 164 x 97 x 140 mm
Weight Approximately 425 g
Operating Temperature and Humidity 10 °C to 40 °C (50 °F to 104 °F); 10 to 85 % RH
Temperature and Humidity of Storage
and Transportation -20 °C to 70 °C (-4° to 158° F); 10 to 95 % RH
The above technical features may be subject to change at the discretion of the producer.
Figure 1: the distribution of atomized
particles (Albuterol sulfate)
Troubleshooting
If any abnormality occurs during use, please check and correct the following:
Condition Correction
Unit does not operate when the ON/OFF
button is pressed.
Check the AC adapter connection to the outlet and/or
check the AC plug in the unit’s AC port. Check whether the
water tank is lled to the correct level.
No misting or a low rate of misting Check whether there is medication in the medication cup. Check the medication cup for damage.
Check whether the transducer is clean.
Fan is not working properly Device must be sent to authorized service company to check whether the fan is rmly and properly mounted on
the motor shaft.

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19
EMC Declaration
Guidance and manufacturer’s declaration – electromagnetic emission
This device is intended for use in the electromagnetic environment specied below. The customer of the
user of the device should ensure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The device only uses RF energy for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference with
nearby electronic equipment.
RF emissions
CISPR 11 Class B
The device is suitable for use in all establishments,
other than domestic 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 Compliant
Voltage uctuations /
icker emissions
IEC 61000-3-3
Compliant

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20
EMC Declaration
Guidance and manufacturer's declaration – electromagnetic immunity
This device is intended for use in the electromagnetic environment specied below. The customer or the
user of the device should ensure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
covered IEC
61000-4-2
Contact: +8 kV
Air: +2,+4,+8,+15 KV
Contact: +8 kV
Air: +2,+4,+8,+15 KV
Floors should be wood, concrete
or ceramic tile. If the oor is with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
The input a.c. power
ports: ±2 KV
The input d.c. power
ports: ±2 KV
Signal input/output
ports: ±1 KV
The input a.c. power
ports: ±2 KV
The input d.c. power
ports: ±2 KV
Signal input/output
ports: ±1 KV
The mains power quality should
be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
Input power ports:
+0.5,+1.0 KV
Signal input/
output:+2.0 KV
Input power
ports:+0.5, +1.0 KV
Signal input/
output:+2.0 KV
The mains power quality should
be that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
in power supply
input lines
IEC 61000-4-11
0.5 cycles for
>95% (sync angle
(degrees):0, 45, 90,
135, 180,225, 270,
315)
1 cycles for >95%
UT (sync angle
(degrees):0)
25 (50Hz)/30 (60Hz)
cycles for 30%
U T (sync angle
(degrees):0) 250
(50Hz)/300 (60Hz)
cycles for >95%
UT (sync angle
(degrees):0)
0.5 cycles for
>95% (sync angle
(degrees):0, 45, 90,
135, 180,225, 270,
315)
1 cycles for >95%
UT (sync angle
(degrees):0)
25 (50Hz)/30 (60Hz)
cycles for 30%
U T (sync angle
(degrees):0) 250
(50Hz)/300 (60Hz)
cycles for >95%
UT (sync angle
(degrees):0)
The mains power quality should
be that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during mains interruptions,
it is recommended that the device
be powered using an uninterruptible
power supply or a battery.
Power frequency
(50Hz/60Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to the application of the test level.