Flaem P0709EM, Инструкция по эксплуатации

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2. Instructions for use
• Before each usage, wash hands thoroughly and clean the nasal douche and its accessories as
indicated in paragraph 3. Cleaning, Sanitization, Disinfection and Sterilization.
• During application it is advisable to be careful as the solution can drip from the nose.
2.1 - Before usage place batteries as indicated in paragraph 1.
2.2 - For a correct use of the nasal douche, the symbol of the little man ( ) (4c), placed on the flask (4),
always has to be directed towards the patient. The flask can be fixed on the position of the little
man on the side of the activation button (5a) allowing activation of the nasal douche with the
thumb, or with the little man on the opposite side of the button in order to allow activation with
the index finger.
In order to obtain one of the aforementioned conditions, when screwing the flask clockwise (4) on
the douche compressor body (5) (fig C.), the symbol of the little man needs to be located on the
side opposite to the position you would like to obtain (fig. C).
2.3 - Pour the solution (max 15 ml) in the nebulisation slot (4a) of the flask, as shown in (fig. E). Verify
the presence of the atomizer (3).
2.4
-
Apply the separator (2) directing it with the dot (2a) in correspondence with the little man ( ) (4c)
located on the external part of the flask (4), as shown in (fig F.). Then insert the most suitable nasal
adaptor for the size of your nasal openings (1A-1B-1C)
2.5 - Insert the hole of the nasal adaptor in one nasal opening (fig. G).
2.6 - Activate the nasal douche by keeping the activation button pressed (5a) during the inhalation
phase and release it before exhaling; in this phase, in order to help the discharge of the mucus,
gently blow through the nasal opening that has been treated with the nasal douche, keeping the
other nasal opening closed.
2.7 - During nebulisation it is advisable to close the other nostril where the douche is not being
applied, with a finger.
2.8 - Repeat procedures
2.5
to
2.7
for the other nasal opening as well, trying to evenly distribute the
solution in the two nasal openings.
2.9 - In the case of children or people who are not self-sufficient, or not able to perform the various
phases of point
2.6,
it is advisable to carry out the application alternating the two nasal openings
after about 15 seconds, with breaks necessary to allow for the discharge of mucus.
2.10 - In case of medicine administration through aerosol, it is advisable to carry out a wash with a
saline solution first, in order to obtain a more efficient distribution of the medicine on the nasal
mucous membrane.
2.11 - At the end of the application, turn off the device and carry out cleaning and/or sanitizing
following the instructions in paragraph 3. Cleaning, Sanitization, Disinfection and Sterilization.
Battery disposal: Exhausted batteries are to be disposed of in the appropriate recipient.
2. Place 2 batteries in the compartment, paying attention to the polarities written inside the
compartment. Use two alcaline batteries (AA).
3. Place the lid back on the compartment by lowering the upper part of the compartment until it is
completely fastened.
Remove the batteries when the device is not going to be used for a prolonged period of time. Leaving
the batteries in the compartment for too long can cause leaking which can damage the device.
ATTENTION:
• Does not contain parts which can be repaired by the user. The warranty does not cover batteries or
damage caused by old batteries.
• Only use good quality batteries. Always use new batteries and do not use old and new batteries
together. Use batteries of the same brand and of the same type.
3. Cleaning, Sanitization, Disinfection and Sterilization. (For clinical
or hospital use only)
A thorough cleaning is extremely important for the lifespan and well-functioning of the device.
After usage, unassemble the nasal douche by following the drawing (see fig A), remove the
batteries and procede with cleaning and/or sanitizing of the components performing the
following operations:
3.1 -
Cleaning: Irrigator compressor body
For component (5) only use a damp cloth with antibacterial detergent (non-abrasive and solvents
free).
The nasal douche has an aspiration valve (5c) which is to be cleaned when dirty. To access the valve
lift the lid of the battery compartment and remove the valve by lifting it with a ballpoint pen (fig
H); then wash the valve with water and detergent. Before reassembling, make sure that the valve is
completely dry.
ATTENTION:
The compressor body of the douche is not protected against the penetration of liquids; therefore do
not wash it with running water or immersion.The compressor body of the douche is not protected
against the penetration of liquids; therefore do not wash it with running water or immersion.
3.2 -
Sanification: Clean the components
(1A-1B-1C-2,3,4)
choosing one of the following methods.
Method A:
Wash the components with hot drinking water (about 40°C) with a delicate dish deter-
gent (non-abrasive).
Method B: through immersion in a solution composed of 50% water and 50 % white vinegar. Then
rinse well with hot drinking water (about 40°C);
Drying:
After washing or sanitizing the components, shake them well and place them on a paper
napkin or dry them with hot air (for example with a blow dryer). Reassemble the nasal douche as
shown in the picture (see fig A).
3.3 - Disinfection: The accessories that can be disinfected are (1A-1B-1C-2,3,4)
Method A: The disinfection procedure described in this paragraph is to be performed before using
the accessories and is effective only if all the prescriptions herein are met and all the components
involved are previously sanitized.
The disinfectant to be used must be of electrolytic oxidizing chlorine type, (active ingredient: so-
dium hypochlorite), specific for disinfection and is available in all pharmacies.
Procedure:
- Fill a container, suitable to contain all the individual components to be disinfected, with a solution of
drinking water and disinfectant, while respecting the proportions indicated on the packaging of the
disinfectant itself.
- Completely immerse each individual component in the solution, taking care to avoid the formation
of air bubbles in contact with the components. Leave the components immersed for the period of
time indicated on the packaging of the disinfectant, and associated with the concentration chosen
to prepare the solution.
- Remove the components now disinfected and rinse thoroughly with lukewarm drinking water.
- Dispose of the solution as recommended by the disinfectant manufacturer.
Method B:
boil in water for 10 minutes; it is advisable to use demineralized water or distilled water
in order to avoid chalky deposits.
After disinfection shake the accessories vigorously and place them on a paper towel, or alternatively, dry
them with a jet of hot air (e.g. using a hair dryer).
3.4 -
Sterilization:
Sterilization intended for clinical or hospital use is the responsibility of the same structure that it per-
forms and must be performed according to the instructions in this manual.
The accessories that can be sterilized are
(2-3-4)
The sterilization procedure described in this paragraph is effective only if all the prescriptions
herein are met, all the components involved are previously sanitized and the procedure itself is
validated according to ISO 17665-1 rule.
Unit: Steam sterilizer with fractionated vacuum and overpressure according to EN 13060 rule.
Procedure:
Package each component to be treated in sterile barrier system or packaging complying
with EN 11607 rule. Place the packed components in the steam sterilizer. Run the sterilization cycle
according to the instructions manual of the device, selecting a temperature of 134° C and a duration
of 10 minutes.
Storage: Store sterilized components as per instructions of the sterile barrier package or system chosen.