Mediblink M480 User manual
1
SLO MediblinkUltrazvočniinhalatorM480
NAVODILA ZA UPORABO
Prosimo, da pred uporabo izdelka v celoti preberete navodila
za uporabo
EN
MediblinkUltrasonicnebulizerM480
INSTRUCTIONS FOR USE
Please read this guidebook completely before operating this unit.
HRV MediblinkUltrazvučniinhalatorM480
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.
EN
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 certied medical experts, such as doctors, nurses and
therapists or healthcare personnel or patients under the guidance of qualied medical
experts for home treatment.
Themedicalconditionstobetreated: 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
overlled.
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 specied 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 deect the nebulizer as there is a risk of medicine leakage and malfunction.
13. Please use the adult mask, a pediatric mask with a CE certicate with notied 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. Testmethod
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.
EN
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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