Pari LC series User manual

LC Family
©2016 PARI GmbH Spezialisten für effektive Inhalation, 022D0103-O 06/16

IMPORTANT INFORMATION.......................................... 5
General............................................................................. 5
Information about the instructions for use ........................ 5
Structure of safety instructions ......................................... 5
Treatment of babies, children and anyone who requires
assistance ........................................................................ 6
Treatment of patients with a surgically created opening
in the windpipe (tracheostoma) ........................................ 6
Hygiene ............................................................................ 7
PRODUCT DESCRIPTION .............................................. 8
Components ..................................................................... 8
Intended purpose ............................................................. 9
Intended use..................................................................... 9
Contraindications.............................................................. 9
Product variants and combinations .................................. 10
Material information.......................................................... 10
Operating life .................................................................... 10
INHALATION ................................................................... 11
Assembling the nebuliser ................................................. 11
Filling with medication ...................................................... 12
Performing the inhalation ................................................. 14
CLEANING AND DISINFECTION AT HOME.................. 15
Preparation....................................................................... 15
Care of the connection tube ............................................. 15
Cleaning ........................................................................... 16
Disinfection....................................................................... 16
Visual inspection .............................................................. 21
Drying and storage ........................................................... 21
Instructions for use
Information as of: 2016-02. All rights reserved. Technical and design changes
and printing errors reserved. Principle shown in illustrations.
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MISCELLANEOUS .......................................................... 22
Disposal............................................................................ 22
Technical data .................................................................. 22
Explanation of symbols .................................................... 23
Contact ............................................................................. 23
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1 IMPORTANT INFORMATION
1.1 General
Please read these instructions for use carefully and completely.
Do not discard, so you can consult them at a later date. If you
fail to comply with the instructions for use, injury or damage to
the device cannot be ruled out.
If symptoms persist or if your condition worsens, discon-
tinue the application and contact your doctor immediately.
1.2 Information about the instructions for use
These instructions for use are intended for the user at
home. A separate copy of instructions for use is available for
medical specialists.
If these instructions for use are lost, you can request another
copy from PARIGmbH [see:Contact, page23]. The instruc-
tions for use for some products can be retrieved on the internet
in both German and English. Simply visit: www.pari.com (on
the respective product page).
1.3 Structure of safety instructions
Safety-critical warnings are categorised according to hazard
levels in these instructions for use:
– The signal word CAUTION is used to indicate hazards
which, without precautionary measures, can result in minor
to moderate injury or impair treatment.
– The signal word NOTICE is used to indicate general pre-
cautionary measures which are to be observed to avoid
damaging the product during use.
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1.4 Treatment of babies, children and anyone
who requires assistance
Babies, children and anyone who requires assistance must be
supervised constantly by an adult during inhalation therapy.
This is the only way to ensure safe and effective treatment. In-
dividuals in this group often underestimate the hazards in-
volved (e.g. strangulation with the power cord or the connec-
tion tubing), thus resulting in a risk of injury.
The product contains small parts. Small parts can block the air-
ways and lead to a choking hazard. Therefore, make sure that
you always keep the compressor, the nebuliser and the ac-
cessories out of the reach of babies and infants.
Special masks may be obtained for treating babies and infants
who are not yet able to inhale using the mouthpiece.
The nebulisers are only designed for patients who are able to
breathe by themselves and are conscious. This is the only way
to ensure effective treatment and avoid a choking hazard.
1.5 Treatment of patients with a surgically
created opening in the windpipe
(tracheostoma)
Tracheostomised patients cannot use the mouthpiece to inhale
and therefore need the PARITRACHEOSET with a special
tracheostoma mask for an inhalation session. When the
tracheostoma mask is used, the inspiratory valve must not be
attached to the nebuliser. This ensures unobstructed expiration
and avoids the risk of shortness of breath.
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1.6 Hygiene
Observe the following hygiene instructions:
– Do not use product components unless they have been
thoroughly cleaned and dried. Contamination and residual
moisture encourage the growth of bacteria, which increases
the risk of infection.
– Before every use and cleaning, wash your hands
thoroughly.
– Make absolutely sure you also carry out cleaning and drying
before using the device for the first time.
– For cleaning and disinfection, always use fresh water with
reduced calcium content.
– Make sure all components are dried properly whenever you
have performed cleaning or disinfection.
– Do not keep the product and accessories in a damp
environment or together with damp objects.
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2 PRODUCT DESCRIPTION
2.1 Components
Check that all components of your PARI product are contained
in your package. If anything is missing, please notify the dealer
from whom you purchased the PARI product immediately.
(1) Nebuliser lower section
(2) Nozzle attachment
(3) Inspiratory valve
(4) Mouthpiece
(5) Child mask soft
(6) Connection tubing (f/f)
(7) Filter insert for compressor
(8) Filter changer
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2.2 Intended purpose
The nebulisers of the PARILCfamily are medication
nebulisers that are designed to be used in conjunction with a
PARIcompressor for inhalation therapy of the lower and/or
upper airways.
Each application generally takes between 5and 10minutes
(depending on the quantity of medication), but in no case more
than 20minutes.
Only original PARIcompressors and PARIaccessories must
be used. PARIGmbH cannot be held liable for damage caused
by using PARInebulisers with compressors or accessories
from other manufacturers.
Please read and follow the instructions for use of the com-
pressor and of the accessories you are using.
2.3 Intended use
The nebuliser is intended exclusively for home use.
For reasons of hygiene, the nebuliser, the mouthpiece and the
masks must only be used by a single patient.
This product is only designed for patients who are able to
breathe by themselves and are conscious.
Only medication that has been approved for inhalation treat-
ment must be used. Take note of any restrictions in the instruc-
tions for use of the medication in question.
2.4 Contraindications
None.
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2.5 Product variants and combinations
The nebulisers of the PARILCfamily can be operated with all
PARI compressors that are available on the market.
The nebuliser is used for treatment of the airways in adults and
children aged approx. 4 years and older. A special baby mask
with baby bend must be used for treating children and infants
who are not yet able to inhale using the mouthpiece.
2.6 Material information
Polypropylene Nebuliser lower section, nozzle attachment,
inspiratory valve, mouthpiece, child mask
Thermoplastic
elastomer
Nebuliser lower section, nozzle attachment,
inspiratory valve, mouthpiece, child mask
Polyester Rubber band
Synthetic rubber
(latex-free)
Rubber band
2.7 Operating life
Replace the nebuliser after a year at the latest as changes can
occur in the material of the nebuliser over time. This might
impair the effectiveness of the treatment.
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3 INHALATION
3.1 Assembling the nebuliser
CAUTION
Check all nebuliser components and the accessories before
each use. Replace any broken, misshapen or seriously
discoloured parts. Please also follow the instructions for as-
sembly given below. Damaged components and/or an in-
correctly assembled nebuliser may impair functioning of
the nebuliser and thus treatment as well.
• Insert the nozzle attachment in
the nebuliser lower section.
• Gently twist the nozzle attach-
ment clockwise to lock it in
place.
• Attach the connection tubing to
the nebuliser.
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Using with a mouthpiece
• Fit the mouthpiece onto the
nebuliser.
Using with a child mask
• Attach the child mask to the
nebuliser.
When using a mask, make sure that the expiratory valve
plate is pressed out so you can exhale freely during an
inhalation session.
3.2 Filling with medication
• Insert the nebuliser in the holder on the compressor
intended for this purpose.
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• Pour the quantity of medication
prescribed by your doctor into
the nebuliser nozzle attach-
ment.
Info: Ensure that the medica-
tion is filled no higher than the
upper scale marking (max.
level 8ml). Overfilling can
greatly impair the nebulisation
of medication.
max. 8ml
• Attach the inspiratory valve to
the nebuliser.
If you are to inhale several medications one after the other in
one application, rinse out the nebuliser with tap water between
inhalations. Remove excess water by shaking the nebuliser
and then fill it with the next medication as described.
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3.3 Performing the inhalation
Before starting the treatment, ensure that all parts are firmly
connected to each other.
Perform the treatment until the aerosol is used up (indicated by
a change in the sound of the nebuliser).
Several drops of medication will remain in the nebuliser
after the treatment has ended.
• Connect the connection tube to the compressor and switch
the compressor on.
• Sit in an upright position and relax.
• Take the nebuliser out of its holder and hold it upright.
• Take the mouthpiece between your teeth and close your lips
around it or press the mask lightly over the mouth and nose.
• Breathe in through the mouthpiece or mask as slowly and
deeply as possible, and then breathe out in a relaxed man-
ner.
• Replace the nebuliser in the holder as soon as you have fin-
ished inhaling.
• Switch the compressor off.
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4 CLEANING AND DISINFECTION AT HOME
The nebuliser and the accessories used must be cleaned
thoroughly after each application and disinfected at least once
a day.
The connection tube cannot be cleaned or disinfected.
4.1 Preparation
• Detach the tubing from the nebuliser.
• Make sure that all medication residues are removed from
the nebuliser.
• Dismantle the nebuliser into its individual parts.
• Carefully pull the blue expirat-
ory valve out of the slot in the
mouthpiece. The valve must
still be attached to the mouth-
piece.
• Rinse all components of the nebuliser under running tap wa-
ter. This must be done especially thoroughly if cleaning and
disinfection are not carried out straight away.
4.2 Care of the connection tube
• Connect the connection tube to the compressor.
• Switch the compressor on.
• Leave the compressor running until any condensation in the
tube has been removed by the air flowing into the tube.
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4.3 Cleaning
• Place all disassembled com-
ponents in warm tap water with
a little dishwashing liquid for at
least 5min. If necessary, use a
clean brush to remove loose
dirt (the brush must be re-
served exclusively for this pur-
pose).
• Rinse all parts thoroughly in running water.
• You can remove excess water more quickly by shaking all
parts.
4.4 Disinfection
After cleaning, disinfect the dismantled nebuliser and accessor-
ies used (except for the connection tube). Effective disinfection
is only possible if the nebuliser has been cleaned.
Information when using masks with rubber bands:
The rubber band can only be cleaned as it might be dam-
aged by the high temperatures used during disinfection.
CAUTION
A damp environment may encourage the growth of bacteria.
Therefore, remove all parts from the pot or disinfector as
soon as disinfection has finished. Dry the parts. The risk of
infection is reduced when the parts are dried completely.
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In boiling water
• Place all the individual parts in boiling water for at least
5minutes.
Use a clean pot and fresh water with reduced calcium
content, if possible.
Plastic will melt if it comes into contact with the hot base of
the pot. Therefore, make sure there is plenty of water in the
pot. This way you will avoid damaging the components.
• You can remove excess water more quickly by shaking all
parts.
Using a standard thermal disinfector for baby
bottles (not a microwave oven)
For effective disinfection, use a disinfector with a runtime of at
least 6minutes. Regarding disinfection, the duration of the dis-
infection procedure and the quantity of water required for this,
follow the instructions for use of the disinfector you are using.
CAUTION
Inadequate disinfection encourages the growth of bacteria
and thus increases the risk of infection. Thorough disinfec-
tion has not been completed until the disinfector automatic-
ally switches itself off, or the minimum disinfection time spe-
cified in the instructions for use of the disinfector has
elapsed. Therefore, do not switch the device off prematurely.
Also make sure that the disinfector is kept clean and regu-
larly check that it is in good working order.
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With a microwave disinfector
Microwave disinfectors ensure effective disinfection of the
product components in a standard commercial microwave
oven.
Place the product components in
the disinfector with enough space
between them to allow the steam
to reach all surfaces reliably.
Maintain the following times when disinfecting:
Wattage Disinfection time Cooling time
850 – 950 4min. 2min.
600 – 850 6min. 2min.
Information about the amount of water required and about the
disinfection process is included in the instructions for use of the
devices in question (disinfector and microwave).
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CAUTION
The product components must not be exposed to microwave
radiation unless they are in a microwave disinfector. If they
are heated in a microwave oven without the protection of the
disinfector, the individual parts will be damaged.
Do not use the grill function because this too will damage
the individual parts.
At the end of the disinfection process, the parts may still be
very hot. Therefore, it is essential to wait for the cooling time
to pass before taking the parts out, otherwise there is a risk
of burns.
Inadequate or ineffective disinfection encourages the growth
of bacteria and thus increases the risk of infection. Disin-
fection is not completed properly unless both the specified
minimum disinfection time and the required power output of
the microwave are observed. The disinfector must also be
perfectly clean. Check regularly that the microwave and the
disinfector are functioning perfectly.
Use only water for disinfection, never use chemicals.
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Chemical cleaning with disinfection
Cleaning and disinfection can be carried out in a single cycle
using a chemical preparation process. For this, use the clean-
ing disinfecting agent Bomix®plus.
To ensure safety when handling chemicals, follow the instruc-
tions for use of the disinfecting agent, particularly the accompa-
nying safety instructions.
CAUTION
Inadequate disinfection encourages the growth of bacteria
and thus increases the risk of infection. Adequate cleaning
with disinfection can only be assured if the specified mixing
ratio and application time are adhered to, and if all individual
parts are completely immersed in the solution for the entire
application time. There must not be any air pockets or
bubbles.
• Prepare a 2% solution of
Bomix®plus by mixing 10ml of
the concentrate with 500ml
tap water.
• Place all the individual parts in
the prepared solution and
leave them to soak for 5min.
If the application period is exceeded significantly, the
plastic parts may take on the smell of the disinfectant.
• Rinse off all parts thoroughly in running water (residues of
the disinfectant can cause allergic reactions or irritations of
the mucous membrane).
• You can remove excess water more quickly by shaking all
parts.
• Dispose of the used solution (the diluted solution can be got
rid of down the drain).
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