Mediblink COMPACT M440 Compressor Nebulizer Instruction Manual

MEDIBLINK Compressor nebulizer COMPACT M440 INSTRUCTIONS FOR USE
These instructions are important
Please keep them for future reference

Introduction

Dear Customer,
Thank you for choosing Mediblink Compact M440 nebulizer, a piston aerosol therapy unit designed and manufactured according the most up-to-date technologies.
Mediblink Compact M440 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 Compact M440 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.

Accessories

A – Adult mask
B – Children & Baby mask
C – Mouthpiece
D – 3-stage nebulizer cup
E – Connection tube
F – Filters
Picture 1: Nebulizer Accessories![Mediblink COMPACT M440 Compressor Nebulizer

• Accessories](https://manuals.plus/wp-content/uploads/2023/10/Mediblink- COMPACT-M440-Compressor-Nebulizer-Accessories.png)

Device Components

G – On/Off switch
H – Compressed air outlet
I – Filter
J – Nebuliser cup support
K – Handle
L – Openings for cooling air
M – Power cord
Picture 2: Nebulizer Components

General warnings

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 effect.
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 certified adapters if the existing legislation in the individual country allows for it or have an Mediblink authorised technician replace the plug.
8. To prevent overheating and damage to the compressor, switch off the appliance for at least 30 minutes after every 30 minutes of uninterrupted use.
9. Caution! Using the appliance before 30 minutes have elapsed may result in motor overheating and cause the safety cut-off devices to activate.
10. To ensure correct operation, make sure that the air filter is dry.
11. Do not use the appliance in the presence of nitrous oxide, oxygen or flammable air/anaesthetic mixtures.
12. Turn off 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 filling.
13. Keep the appliance and power cord away from hot surfaces.
14. 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.
15. Never touch the appliance with wet or damp hands.
16. 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 qualified technician.
17. Do not block the openings for cooling air.
18. Do not use the device if you feel drowsy.
19. 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.
20. Do not use connectors or accessories not recommended by the manufacturer.
21. Make sure the appliance is placed on a level, stable surface when used in order to prevent spillage.
22. During use, the surface must be free of any objects that may obstruct the correct flow of air.
23. Use the appliance only in vertical position.
24. Never leave the appliance plugged in when it is not in use or when it is unattended.
25. Before cleaning or performing any maintenance work on the appliance, disconnect it from the mains by pulling the plug out of the electrical socket.
26. If you decide to no longer use the appliance, disconnect from the mains and cut off 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.
27. 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.
28. 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.
29. In the case of failure or malfunction of the appliance, switch it off 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.

3-stage nebuliser cup

The effectiveness of aerosol therapy depends on the quality of medicine diffusion 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 3-stage nebulizer cup produces particles as small as 3,34 μm (MMAD), so approximately 78% of particles achieves lower airways, all the way to lungs alveoli (PORR).
Mediblink 3-stage nebulizer cup also enables the user to set the nebulization rate to 3 different levels: MIN (0,12 ml/min), MED (0,20 ml/min) and MAX (0,30 ml/min).
The nebulization rate (speed) can be changed with a combination of pressing the BUTTON (options MIN/MAX) on the top of the nebulization cup (Picture 3a) and switching up and down the blue core, called SPRAY NOZZLE (options MIN/MAX), located inside the nebulizer cup (Picture 3b).
Table 1: Nebulizer cup nebulization rate settings: MIN / MED / MAX

NEBULIZATION TIME
(5ml of saline solution)| 16 min| 25 min| 25 min| 40 min

The button on the top of the nebulizer cup can be switched when the nebulizer is in use. The switch inside the nebulizer cup must be set to MIN or MAX before the nebulizer is used and before the saline solution or medicine is put in to the nebulizer cup.
Picture 3a: Nebulizer cup partsPicture 3b: Nebulizer cup parts

2 Masks: for adults and children

Soft masks which adapts to your face, minimising drug waste. The masks were designed to ensure correct and efficient therapy for children and adults alike.
Adults should breath throug the mouth, as this is the most efficient way to deliver the flow 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.

Mouthpiece

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 efficacy.

Preparing and using the appliance

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/off 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 off the nebuliser cup walls. Resume the treatment session, which will be finished when no more nebulised solution is released from the nebuliser cup;
11. Once the treatment session is completed, switch the appliance off, unplug it, remove the accessory used and clean the appliance and accessories according to the instructions in the Cleaning and Maintenance paragraph.

Cleaning and maintenance

Cleaning and maintenance of the compressor nebulizer
Warning!
Do not wet the device or put it into water or other liquids. For cleaning, use a clean, dry cloth only.
Cleaning and maintenance of the nebuliser cup and accessories
After each use, remove and detach all the nebulizer components and separately flush 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 inflammable 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.

Checking and replacing filters

Periodically check the condition of the filter. The filter was inserted to protect the compressor. Correct filter maintenance prolongs the life of the nebulizer. The frequency with which filter should be replaced depends on the conditions in which the unit is used.
The filter is located on the front of the nebulizer.
To replace the filter:

1. Open the filter cover cap;
2. Remove the filter to be replaced from its housing;
3. Carefully fit the new filter;
4. Fit the filter cover cap back on.

Warning!
Never leave the filter cover cap and/or filters unattended: These are small parts posing the risk of suffocation if swallowed by children.

Technical specifications

After using the device, the voice level can change.
Nebulization rate:| MIN ≥ 0,12 ml/min; MAX. ≥ 0,3 ml/min
Medicine leftover:| 0.8 ± 0.05 ml
Medical device classification:| IIb

EMC tables

Guidance and manufacturer’s declaration — electromagnetic emissions

The Mediblink Compact Nebulizer M440 (JLN-2313AS) is intended for use in the electromagnetic environment specified below. The customer or the user of the JLN-2313AS should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The JLN-2313AS 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 The JLN-2313AS 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 fluctuations/flicker
emissions IEC 61000-3-3
Complies|
Guidance and manufacturer’s declaration – electromagnetic immunity

TheJLN-2313AS is •ntencled for use in the electromagnetic environment specified below. The customer or the user of the JLN-2313AS 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 floors 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 5s| <5% UT for 0.5 cycle
40% UT for 5 cycles
70% UT for 25 cycles
<5% UT for| Mains power quality should be that of a typical commercial or hospital environment. If the user of the JLN-2313AS requires continued operation during power mains interruptions, it
is recommended that the JLN2313AS be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8| 3 Alm| 3 Alm| Power frequency magnetic fields should be at levels charactedstic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration — electromagnetic immunity

The JLN-2313AS is intended for use in the electromagnetic environment specified below. The customer or the user of the JLN-2313AS 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 JLN-2313AS, 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 fixed 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:

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 JLN-2313AS

The JLN-2313AS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the JLN- 2313AS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the JLN-2313AS 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
1| 1,2| 1,2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23

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 reflection from structures, objects and people.

Legend of symbols

| Caution!
---|---
| Consult instructions for use Electronic instructions for use:
http://www.mediblink.com/f/m440.pdf
| Double insulation
| Keep dry (the appliance is not
provided with specific protection
against the penetration of liquids)
| Product ID number
| Medical device Class IIa
| LOT number*
| Device with Type BF applied part
| Complies with directive
MDD 93/42/EEC + 2007/47/EC
| Alternate current
| Serial Number
| Number of products in one packaging
****| Manufacturer
| European Union Representative

*Date of manufacture: first pair of LOT numbers presents the month of manufacture, the second pair of numbers presents the year of production. Example: LOT 1019 = October, 2019.

Conditions for storage and transportation

| Relative humidity: 30 % / 75 %
---|---
| Store in a cool, dry place.
| Temperature: -10 °C / +55 °C

Environmental conditions during use

| Relative humidity: 45 % / 75 %
---|---
| Temperature: -10 °C / +40 °C

**** 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.

Warranty

Product: Mediblink Compressor Nebulizer Compcat M440
Manufactured for (also EU importer): Mediblink d.o.o., Gubčeva cesta 19, 8210 Trebnje, Slovenia; info@mediblink.com; 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 fill in this field.
WARRANTY TERMS
Dear customers!
The warranty period is 5 years and starts from the day of product purchase. The warranty period on spare parts: masks, mouthpiece, tube and filters 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, fire 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 flaws. 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 flawless 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 (Shenzhen Homed Medical Device CO., Ltd.), company Mediblink d.o.o. and the competent authority of the Member State in which the user and/or patient is established.
Exclusive representative for Slovenia:
Prolat d.o.o.
Praproče 9
8210 Trebnje – SLO
Tel: +386(0)30-44-555
info@prolat.si
Service and claims: servis@prolat.si
www.prolat.si
Exclusive representative for Croatia:
Golia d.o.o.
XI Vrbik 3
10000 Zagreb
Tel: (01) 61-98-496
info@golia.hr
Service and claims: servis@golia.hr
www.golia.hr
Manufactured for
(EU importer):
Mediblink d.o.o.
Gubčeva cesta 19
8210 Trebnje
Slovenia
info@mediblink.com
www.mediblink.com

Shenzhen Homed Medical Device CO., Ltd.
3rd Floor, Block 1, Longquan Industrial Zone,
Huarong Road, Dalang Street, Longhua New District,
Shenzhen 518109, People’s Republic of China Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany Instructions for use version No.:
M440-21.02.2019-2
Instructions for use issue date:
21. 2. 2019
Date of last correction:
10. 12. 2021

References

• Mediblink.si
• Golia.hr
• Mediblink.com
• Mediblink.si
• Prolat.si

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