Medinox EASY-BREATHE II User manual

USER MANUAL
KEEP THIS MANUAL IN A SAFE PLACE
OPERATING INSTRUCTIONS
1. Position the appliance on a stable surface.
2.
3. Connect the tube (1) to the appliance and run the nebuliser for 1 minute to ensure no moisture is present in the tubing.
4. Connect the nebulising ampoule (2) to the appliance, using the tube (1).
5. Connect one of the desired accessories to the nebulising ampoule: mouthpiece (4), nosepiece (5) or mask (6), as indicated
in the accessory connection diagram on page 2. The nosepiece can only be used if the nebulising ampoule is closed (refer
to point 6, Fig A).
6. The nebulising ampoule can be adjusted according to the nebulisation rate required, as depicted in the diagram below.
Important instructions about using the nebulising ampoule.
The plastic Neboplus ampoule (2) can be used in two different ways:
• with the plug (3) inserted, for slow nebulisation (Fig. A);
• with the plug (3) open, for standard nebulisation (Fig. B).
7. In
diagram (minimum 0.5 ml, maximum 8 ml).
8. Insert the plug into the power supply socket after having checked that the power supply voltage corresponds to the rated
voltage indicated on the label located under the appliance.
9. Start the appliance using the switch, bearing in mind that it may be tested for intermittent operation. The emission of vapour
to have a peculiar smell which disappears after a few uses.
10.
nebulised. The quantity not nebulised, as with the nebulisation speed, depend on the medicine characteristics. For example,
11. Once the application has been completed, switch the appliance off and remove the plug from the power supply.
12.To avoid the risk of infection, clean the appliance and the accessories as indicated below.
CLEANING THE APPLIANCE
All cleaning operations must be performed with the plug of the appliance removed from the power supply socket. To avoid
anomalous appliance operation and the inhalation of undesired substances, clean the appliance and accessories immediately
after performing the treatment. The appliance and the accessory storage area should be cleaned using a cloth slightly
moistened with surgical alcohol. After cleaning the appliance, ensure that all alcohol has evaporated before re-use. Do not use
other liquids or substances for cleaning purposes. Do not use a wet cloth - if liquids come into contact with the electrical parts
of the appliance, operating defects or irreparable damage may be caused.
CLEANING THE ACCESSORIES
After use, and if necessary, before use, wash the accessories (not including the tube) carefully with tepid water and dry
them with a cloth. Then put the accessories into a clean storage area. When cleaning, ensure that all residue is removed
into contact with the skin or mucous, if ingested or inhaled. If it is necessary to disinfect the accessories, adopt the methods
approved by the regulations in force and in compliance with the resistance of the material.
Any residual humidity in the tube may be removed by leaving the aerosol nebuliser switched on without the ampoule connected
for a few minutes. If the tube is dirty, it should be replaced.
®
The accessories (not including the tube) may be disinfected using specific products such as the MILTON
method: they should
be rinsed to remove all traces of disinfectant, dried and stored in a dry and clean environment.
The accessories may be disinfected in boiling water (100°C) for at least 40 minutes or in an autoclave (120°C) for at least 20
minutes. Do not boil the tube. Do not put weights on the accessories and do not bend them; do not exceed the temperatures
indicated; After disinfection, store in clean bags. PVC accessories will lose their transparency in water or vapour;
this phenomenon will disappear after a few days in a dry environment and will not affect usability. All the accessories may be
disinfected up to a maximum of 100 times, following which they should be replaced. The frequency and interval between one
disinfection session and another should be established according to the discretion of the doctor and/or the clinic and according
to the pathology. The accessories should normally be disinfected prior to each change of patient. Do not wash the accessories
in a washing machine.
code NEB03. 10/2016
REPLACING THE FILTER
, and assess for possible replacement.
tweezers.
PERIODIC CHECKS
months for frequent use – 3 applications per day). Damaged accessories should be replaced.
Although a correctly used appliance can last a very long time, we recommend to replace it after no more than 10 years
or a thousand working hours from the manufacturing date. Periodically, or in case of doubt about the performance of the
appliance, verify that the “Amount nebulised” with open plug (3) is within 50% of the declared value. The test have to be
performed using 4 ml of physiological solution. If the unit’s performance is not within the declared value, replace all the
WASTE DISPOSAL
Dispose of the nebuliser and its accessories in compliance with the local environmental regulations. Do not dispose
of this appliance in the environment. In case of doubt please call your local authorities.
TERMS AND CONDITIONS OF WARRANTY
• We warrant the MX EASY-BREATHE II Nebuliser to be free of defects in workmanship and materials within the said
two year (24 months) warranty period.
• During the warranty period, if the nebuliser is found to be defective, you may return it, together with the purchase receipt
the whole product as we may choose, at no charge to the original owner. After such repair, replacement or exchange, the
product will be warranted for up to the remainder of the period.
• This warranty is void if this product has been repaired or serviced by an unauthorised person. This warranty does not
human control.
• Except as stated in the above paragraphs, we disclaim all other warranties, implied or expressed, including the warranties
direct, consequential or incidental damages arising out of the use or inability to use this product.
Fig. A Fig. B
4 5
cod: NEB03 03/03/2016 8.38.37
and that the accessories are dried properly. Under no circumstances should you use substances that may be toxic if they come
Code: NEB03
COMPRESSOR
EASY-BREATHE II
NEBULISER
HEALTH
2 Sunrock Close, Sunnyrock,
Germiston
Gauteng, 1401
www.medinox.co.za
™
2 Sunrock Close, Sunnyrock,
Germiston
Gauteng, 1401
www.medinox.co.za
™
Applicant:
DATE OF PUBLICATION - April 2020
13. Should the desired results after nebulising not be achieved, please contact your healthcare professional.

2
* For the models sold outside of the European Union, please refer to the data label on the appliance.
SPECIFICATIONS:
• Operating Pressure: 0.8 bar
• Noise Level: 35 dBA
• Filter Size: 13 mm
• Storage Temperature: -40 - 70 ‘C
• Operating Temperature: 5 - 40 ‘C
• Storage Relative Humidity: 10 - 100%
• Operating Relative Humidity: 10 - 93%
• Atmospheric Pressure for Storage & Operation: 500 - 1060 hPA
• Warranty Period: 2 years
1
2
3
5
4
10
11
12
13
3
MAX 8 ml
MIN 0.5 ml
6
7
ø 13 mm
8
8
9
0051 230 V ~50 Hz 220 VA
*
1. Tube
2. “Neboplus” nebuliser
3. Plug for ampoule
4. Mouthpiece
5. Nosepiece
6. Mask
7. Joint (optional)
8. Filter
9. Filter cap
10. Bottom of nebuliser
11. Pixper
12. Selector
13. Upper part of nebuliser
Class II appliance
Type BF appliance
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Aerosol Output (ml) (EN 13544-1) 0.20
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PARTICLE SIZE DISTRIBUTION*
CUMULATIVE UNDERSIZE PERCENTAGE (%)
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AEROSOL THERAPY SYSTEM FOR DOMESTIC USE
IMPORTANT WARNINGS: Failure to follow the warnings and the content of the present manual can expose to
environmental contamination.
• Read all the instructions carefully before using the appliance;
•
compliant with the safety standards in force, paying attention not to exceed the rated current value and the maximum power
value indicated on the adapter;
• The inhalation of any substance must be prescribed and monitored by the healthcare professional, who will indicate the
treating doctor;
• Electricity supply failure, an unexpected fault or any other unfavourable condition may result in operational failure of the
appliance; we therefore recommend that you have an appliance or medicine (subject to agreement with your healthcare
professional) available for use as an alternative.
• Only use the appliance for the use foreseen (aerosol inhalations) and as described in this manual;
• Do not let children or incapable persons use the appliance without supervision; in such cases, pay special attention during
treatment;
• Do not use the appliance if the appliance housing or power supply cable are damaged;
• Never leave the appliance and all its parts, including packaging, within the reach of children, uncapable people, domestic
animals or insects.
LATEX
• The elastic bands (optional) can include latex (LATEX). Latex can produce allergic reactions.
• Do not use the appliance with wet or damp hands or while taking a bath; Do not wet the appliance with water or other liquids;
do not use the appliance if it has accidentally become wet;
• Keep the appliance and the power supply cable away from sources of heat; The appliance is not suitable for use in the
• Do not use the appliance in rooms where sprays have just been used; air the room well before proceeding with the therapy;
• Do not block or obstruct the appliance air openings and do not place it on a soft surface such as a bed or settee;
• Do not insert any objects into the cooling openings; Do not use the appliance in cases where it makes unusual noises;
• To guarantee the performance, functionality and safety of the appliance, only use Norditalia original accessories and spare
parts.
• We recommend personal use of the accessories; In order to reduce the risk of infection, we recommend the disinfection of
all accessories before each use.
• Do not pull the power supply cable or the appliance to remove the plug from the power supply socket. Always remove the
plug after use. In case of a detachable cable always remove the plug from the wall socket before detaching the cable from
the appliance.
• Do not leave the appliance exposed to atmospheric agents; store it in the environmental conditions indicated.
• Do not wrap the tubing or the power cable around your neck.
• The appliance includes some small parts which can be dangerous if inhaled or swallowed.
• Do not operate the appliance in combination with other appliances and accessories not described in the present manual.
• Do not operate the device if stored in dirty places.
RESPONSIBILITY
The manufacturer, his representative, or the importer shall only be considered responsible in terms of safety, performance and
reliability if:
• The assembly technique, calibration, repairs or amendments have been performed by persons authorised by them.
• The electrical system complies with the standards in force.
• The operating instructions have been respected.
The manufacturer declines all responsibility for damage deriving from improper, erroneous and unreasonable use. With time the
product may deteriorate. The product is no longer deemed useable 10 years post manufacturing (manufacturing date stated on
appliance label), and the manufacturer can not be held responsible for damages or incidents caused by the product.
SAFETY FUSE
A safety fuse is housed within the appliance and it may be replaced if it blows. As for all other possible repairs, the replacement
operation must be performed by the manufacturer or by personnel authorised by the same.
ELECTROMAGNETIC COMPATIBILITY
The appliance is compliant with the electromagnetic compatibility standards currently in force and is suitable for use in all
buildings, including those for residential / domestic use. The RF emissions from the appliance are very low and are not likely
to cause any interference with nearby appliances. Avoid positioning the appliance on top of or near other appliances. If the
nebuliser does appear to be interfering with your electrical appliances, move it or connect it to a different electrical socket. Radio
appliances may affect the functioning of the appliance - keep them at least 3 metres away.
NEBULISER COMPONENTS NEBULISATION RATE AND PARTICLE SIZE DISTRIBUTION:
INDEX OF SYMBOLS
1 2 3
cod: XXXXXXXXXX
INTENDED USE:
The mx™ Easy-Breathe II nebuliser is
designed to assist in the treatments of;
asthma, chronic bronchitis, allergies and
other respiratory disorders. The piston
compressor converts prescribed
medication into an aerosol of microscopic
droplets for inhalation via mask or
mouth-piece. It is suitable for all ages.
This manual suits for next models
1