Pari LC plus User manual

Instructions for use
PARI LC PLUS®
PARI LC STAR®
PARI LC PLUS® Baby
Model: PARI LC PLUS (Type 022)
Nebulisers for PARI inhalation systems
Important: Read these instructions carefully before using
the product for the first time. Follow all instructions and
safety instructions!
Keep the instructions in a safe place.
en

Identification, validity, version
These instructions for use are valid for PARInebulisers
(Type022) in the following countries:
Countries outside the EU
Version of these instructions for use: VersionF – 2020-02,
Approved version dated2019-11-15
Information as of: 2019-11
The current version of the instructions for use can be down-
loaded from the internet as a PDF file:
www.pari.com (on the respective product page)
Formats available for visually impaired patients
The instructions for use available in PDF format on the internet
can be enlarged for printing.
CE conformity
This product satisfies the requirements of 93/42/EEC (Medical
devices).
Trade marks
The following trade marks are registered trade marks of
PARIGmbH Spezialisten für effektive Inhalation in Germany
and/or other countries:
LC SPRINT®,LCPLUS®,PARI®
Copyright
©2020 PARIGmbH Spezialisten für effektive Inhalation
Moosstraße3, 82319Starnberg, Germany
No part of this documentation may be reproduced or pro-
cessed, duplicated, translated or disseminated by electronic
means without the prior, written consent of PARIGmbH.
All rights reserved. Technical and design changes and printing
errors reserved. Principle shown in illustrations.
Legal manufacturer
PARIGmbH Spezialisten für effektive Inhalation
Moosstraße3, 82319Starnberg, Germany
– 3 –

Contact
For all product information and in the event of defects or ques-
tions about usage, please contact our ServiceCenter:
Tel.: +49(0)8151-279220 (international)
+49(0)8151-279279 (German-speaking)
E-Mail: [email protected]
– 4 –

TABLE OF CONTENTS
IMPORTANT INFORMATION.......................................... 7
Intended purpose ............................................................. 7
Indication .......................................................................... 8
Contraindications.............................................................. 8
Safety instructions ............................................................ 8
PRODUCT DESCRIPTION .............................................. 11
Components ..................................................................... 11
Product variants ............................................................... 12
Product combinations....................................................... 12
Description of function...................................................... 12
Material information.......................................................... 13
Operating life .................................................................... 13
USE .................................................................................. 14
Preparing for treatment .................................................... 14
Performing treatment........................................................ 17
Ending the treatment ........................................................ 19
REPROCESSING ............................................................ 20
Preparation....................................................................... 20
Cleaning ........................................................................... 20
Disinfecting....................................................................... 21
Care of the connection tube ............................................. 22
Inspecting ......................................................................... 22
Drying ............................................................................... 22
Storage............................................................................. 23
TROUBLESHOOTING..................................................... 23
TECHNICAL DATA.......................................................... 23
General nebuliser data ..................................................... 23
Aerosol data according to ISO27427 .............................. 24
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MISCELLANEOUS .......................................................... 26
Disposal............................................................................ 26
Labelling ........................................................................... 26
APPENDIX: Reprocessing in professional environ-
ments for use with several patients ............................. 27
Nebuliser .......................................................................... 27
Connection tubing ............................................................ 29
– 6 –

1 IMPORTANT INFORMATION
1.1 Intended purpose
Aerosols1 for inhalation are generated with the PARILCPLUS,
PARILCSTAR and PARILCPLUSBABY nebulisers.
Together with a PARIcompressor and PARI accessories, the
nebuliser forms an inhalation system for treatment of the lower
airways.
The nebuliser is suitable for use in treating patients in all age
groups.
Only solutions and suspensions that are approved for use in
nebuliser therapy may be used.
The nebuliser must only be used with a PARIcompressor.
For reasons of hygiene, this PARIproduct must only be used in
a home environment by a single patient.
The inhalation system must only be used by individuals who
understand the contents of the instructions for use and are able
to operate the inhalation system safely. Individuals in the fol-
lowing groups must be supervised by a person who is respons-
ible for their safety:
– Babies, infants and children
– Individuals with limited capabilities (e.g., physical, mental,
sensory)
If the patient is not able to operate the inhalation system safely
himself, the therapy must be carried out by the responsible
person.
An application takes between 5and 10minutes (depending on
the quantity of fluid), but in no case more than 20minutes.
The frequency and duration of use will be determined by the
physician or therapist according to the individual needs of the
patient.
1) Aerosol: Small particles of solid, liquid or mixed composition (fine "mist")
suspended in gases or air.
– 7 –

1.2 Indication
For treatment of diseases of the lower airways.
1.3 Contraindications
This product is only designed for patients who are able to
breathe by themselves and are conscious.
1.4 Safety instructions
The present instructions for use contain important inform-
ation, safety instructions and precautionary measures.
The user must follow these in order to guarantee safe op-
eration of this PARIproduct.
This PARI product must only be used as described in these in-
structions for use.
The instructions for use of the compressor and accessories
used and the information for use of the inhalation solution used
must also be followed.
General
Nebuliser aerosol characteristics differ from the information
provided by the manufacturer if non-approved solutions or sus-
pensions are used for nebulisation.
This product is not suitable for use in an anaesthetic breathing
system or a ventilator breathing system.
Tracheotomised patients cannot inhale with a mouthpiece. For
inhalation therapy, they require specific equipment. In this
case, please contact your doctor for further information.
If your health condition is not improved, or even worsens as
a result of the treatment, seek professional medical advice.2
2) Professional medical staff: Doctors, pharmacists and physiotherapists.
– 8 –

Hazard due to small parts which can be
swallowed
The product contains small parts. Small parts can block the air-
ways and lead to a choking hazard. Keep all components of
the product out of the reach of babies and infants at all times.
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.
– It is essential to clean and dry all product components be-
fore the first application as well.
– Always use drinking water for cleaning and disinfecting.
– Dry all product components completely after each cleaning
and disinfection.
– Do not keep the product components in a damp environ-
ment or together with damp objects.
Treatment of babies, infants, and anyone who
requires assistance
For individuals who are not able to perform the therapy session
without assistance or cannot appreciate the hazards, the risk of
injury is greater (e.g., strangulation with the power cord or the
connection tubing). Such individuals include for example ba-
bies, children and people with limited capabilities. For these in-
dividuals, a person responsible for safety must supervise or
carry out the application.
– 9 –

Identifying and classifying warning instructions
Safety-critical warnings are categorised according to the follow-
ing hazard levels in these instructions for use:
DANGER
DANGER indicates a hazardous situation which will lead to
severe injuries or death if it is not avoided.
WARNING
WARNING indicates a hazardous situation which can lead to
severe injuries or death if it is not avoided.
CAUTION
CAUTION indicates a hazardous situation which can lead to
mild or moderate injuries if it is not avoided.
NOTE
NOTE indicates a situation which can lead to material dam-
age if it is not avoided.
– 10 –

2 PRODUCT DESCRIPTION
2.1 Components
The following components are included in the package:
1
1e
1c 1b 1a
1f
1d
2
(1) Nebuliser
(1a) Inspiratory valve
(1b) Nozzle insert
(1c) Nebuliser lower part
(1d) LCinterrupter3
(1e) Mouthpiece3
(1f) Connection tubing3
(2) Air filter for compressor3
3) Not included with all product variants.
– 11 –

2.2 Product variants
The PARILCPLUSnebuliser is available in various versions
for different age groups and requirements:
– PARILCPLUS (nozzle insert: transparent)
With mouthpiece for treatment of the airways in adults and
children aged approx. 4years and older.
– PARILCSTAR (nozzle insert: red)
With mouthpiece for treatment of the deep airways in adults
and children aged 4years and older.
– PARILCPLUSBABY (nozzle insert: red)
With PARIBABYmask and PARIBABYbend for treatment
of the airways in babies (including premature babies) and
children (aged 0-4years).
Not all products are available in all countries.
2.3 Product combinations
The PARInebuliser can be operated with all
PARIcompressors. It can be used in combination with a range
of PARIaccessories.
2.4 Description of function
The PARInebuliser is part of a PARIinhalation system.
Compressed
air
Aerosol
Ambient air
Liquid
When compressed air is supplied,
the nebuliser generates an aero-
sol from the liquid, for example
the medication with which it is
filled. This aerosol is breathed
into the lungs through the mouth-
piece or optionally a mask.
– 12 –

The LCinterrupter makes it possible to interrupt aerosol gener-
ation while the patient breathes out, thereby optimising medica-
tion use.
2.5 Material information
The individual product components are made from the follow-
ing materials:
Product component Material
Inspiratory valve Polypropylene, silicone
Nozzle insert Polypropylene
Nebuliser lower part Polypropylene
LCinterrupter Polypropylene
Mouthpiece (with
exhalation valve)
Polypropylene, thermoplastic
elastomer
Connection tubing Polyvinyl chloride
Tubing endpiece Thermoplastic elastomer
2.6 Operating life
The individual product components have the following expec-
ted operating lives:
Product component Operating life
Nebuliser (all components
except the connection tubing)
300disinfections, max. 1year
Connection tubing max. 1year
– 13 –

3 USE
People who assist others in carrying out the therapy must
ensure that all of the steps described below are carried out
correctly.
If the nebuliser is to be operated via a PARI CENTRAL on a
central medical gas supply, the instructions for use of the
PARICENTRAL must be followed.
3.1 Preparing for treatment
Assembling the nebuliser
CAUTION
Risk of impaired treatment
Damaged components and/or an incorrectly assembled
nebuliser may impair functioning of the nebuliser and thus
treatment as well.
• Check all nebuliser components and the accessories be-
fore each use.
• Replace any broken, misshapen or seriously discoloured
parts.
• Follow the assembly instructions in these instructions for
use.
• Insert the nozzle insert in the
nebuliser lower section.
• Gently twist the nozzle insert
clockwise to lock it in place.
– 14 –

• Attach the connection tubing to
the nebuliser.
Or:
• Attach the LCinterrupter to the
nebuliser.
• Insert the connection tubing in
the air inlet on the side of the
LCinterrupter.
Using the mouthpiece
• Fit the mouthpiece onto the
nebuliser.
Using accessories
Information on assembling accessories is included in the in-
structions for use of the respective accessory.4
4) Instructions for use of accessories are included with the respective
accessory. They can also be ordered from the manufacturer or dealer.
– 15 –

Filling the nebuliser
• Insert the nebuliser in the holder on the compressor in-
tended for this purpose.
• If applicable, detach the inspiratory valve from the nebuliser.
• Pour the required quantity of
inhalation solution into the top
of the nebuliser.
Note the minimum and
maximum fill volumes
[see:General nebuliser data,
page23]. If the nebuliser
contains too little or too much
liquid, the nebulisation and
consequently the therapy will
be less effective.
• Fit the inspiratory valve onto
the nebuliser.
If several inhalation solutions are to be used one after the
other:
• Rinse the nebuliser out with drinking water between the indi-
vidual applications.
• Shake excess water out of the nebuliser.
• Fill the nebuliser with the next inhalation solution as
described.
– 16 –

3.2 Performing treatment
All of the safety instructions in these instructions for use
must have been read and understood before any treatment
is carried out.
Always hold the nebuliser upright during treatment.
Proceed as follows in order to carry out the treatment:
• Insert the connection tubing of
thenebuliser with a slight twist
into the air connection on the
compressor.
DANGER!Life-threaten-
ing situation caused by mix-
ing up tubes! If tubing sys-
tems for other devices are
present close by (e.g., for infusions), check carefully to en-
sure that the other end of the connection tubing connected
to the compressor is connected to the nebuliser. Otherwise,
there is a danger that different possible connections may be
confused with each other.
• Take the nebuliser out of its
holder and hold it upright.
• Verify that all parts are firmly
connected to each other.
– 17 –

• Switch the compressor on.
DANGER!Danger of
death by electrocution in the
case of device fault! Switch
the compressor off and discon-
nect the power plug from the
mains socket immediately if a
fault is suspected (e.g., follow-
ing a fall or if there is a smell of
burning plastic). If there is a fault in the device, it may be
possible to come into contact with live parts. This in turn
may lead to an electric shock.
• Check that an aerosol is being generated before you begin
the treatment.
Inhaling with the mouthpiece
• Sit in an upright position and relax.
• Hold the mouthpiece between your teeth and enclose it with
your lips.
• Breathe in as slowly and deeply as possible through the
mouthpiece, and out again calmly.
• Carry out the inhalation treatment until the noise in the
nebuliser changes.
Some residual fluid will remain in the nebuliser after the end
of the treatment.
– 18 –

Using the LCinterrupter
If the LCinterrupter is attached, aerosol is not generated until
the interrupter button is pressed. Proceed as follows to inhale
and to interrupt aerosol generation when breathing out:
• Press the interrupter button to
generate aerosol.
Info: If the button cannot be
pressed, it is locked and the
LCinterrupter has been set for
permanent nebulising. In this
case, unlock the interrupter
button by turning it counter-
clockwise as far as it will go.
• Release the button to interrupt aerosol generation.
If you want to use the permanent nebulising function even with
the LCinterrupter fitted:
• Turn the interrupter button
clockwise as far as it will go.
ÆThe aerosol is generated per-
manently (permanent
nebulising).
Inhaling with accessories
Inhalation with accessories (e.g., masks) is described in the in-
structions for use of the respective accessory.
3.3 Ending the treatment
To end the treatment, proceed as follows:
• Switch the compressor off.
• Place the nebuliser back in the holder on the compressor.
• Disconnect the power plug from the mains socket.
Complete disconnection from the mains is only certain when
the power plug has been unplugged from the socket.
– 19 –

4 REPROCESSING
The product components must be cleaned thoroughly immedi-
ately after each use and disinfected at least once a day.
If the nebuliser is used in professional environments, follow
the information on reprocessing included in the appendix at the
end of these instructions for use.
4.1 Preparation
• Detach the tube from the nebuliser.
• Detach the mouthpiece from the nebuliser.
• Make sure that all residual volume is removed from the
nebuliser.
• Dismantle the nebuliser into its individual parts.
• Carefully pull the blue exhala-
tion valve out of the slot in the
mouthpiece. The exhalation
valve must still be attached to
the mouthpiece.
4.2 Cleaning
The connection tube cannot be cleaned or disinfected. Re-
garding care of the connection tube, follow the instructions
in the corresponding section [see:Care of the connection
tube, page22].
• Briefly rinse all parts used in running drinking water
beforehand.
• Place all disassembled com-
ponents in warm drinking water
with a little dishwashing liquid
for about 5min.
• Rinse off all parts thoroughly in drinking water.
• Shake the water out of all of the parts.
– 20 –