Pari LC PLUS 022 User manual

Instructions for use
PARI LC PLUS®
Model: PARI LC PLUS (Type 022)
Nebulisers for PARI inhalation systems
en

Read the instructions for use
Read these instructions for use carefully before using the
product. Follow all instructions and safety instructions. Keep
the instructions for use in a safe place.
Validity of instructions for use
PARILCPLUS nebuliser (Type022)
Contact
E-mail: [email protected]
Tel.: +49(0)8151-279220 (international)
[phone]279 (German)
Copyright
©2022 PARIGmbH Spezialisten für effektive Inhalation
Moosstrasse3, 82319Starnberg, Germany. Technical and
design changes and printing errors reserved. The same applies
to illustrations.
Disclaimer
These instructions for use describe the components of
PARIproducts and optional accessories. For this reason, these
instructions for use also describe and illustrate features not
present in your PARI product because they are, for instance,
country-specific and/or optional. When using the systems,
products and functions, the applicable country-specific regula-
tions must be observed.
Trade marks
Registered trade marks of PARIGmbH Spezialisten für effekt-
ive Inhalation in Germany and/or other countries:
LCPLUS®,PARI®
– 2 –

TABLE OF CONTENTS
IMPORTANT INFORMATION.......................................... 5
Intended purpose ............................................................. 5
Indication .......................................................................... 6
Contraindication ............................................................... 6
Labelling ........................................................................... 7
Safety and warning instructions ....................................... 8
PRODUCT DESCRIPTION .............................................. 11
Components ..................................................................... 11
Overview and product designations ................................. 11
Product variants ............................................................... 11
Product combinations....................................................... 12
Description of function...................................................... 12
Material information.......................................................... 13
Service life........................................................................ 13
USE .................................................................................. 14
Preparing for treatment .................................................... 14
Performing treatment........................................................ 18
Ending the treatment ........................................................ 21
REPROCESSING IN A HOME ENVIRONMENT............. 22
Reprocessing cycles ........................................................ 22
Processing limits .............................................................. 22
Preparation....................................................................... 22
Cleaning ........................................................................... 23
Disinfecting....................................................................... 25
Care of the connection tubing .......................................... 27
Inspecting ......................................................................... 27
Drying ............................................................................... 27
Storage............................................................................. 27
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REPROCESSING IN PROFESSIONAL HEALTH INSTI-
TUTIONS.......................................................................... 28
Reprocessing cycles ........................................................ 28
Processing limits .............................................................. 28
Nebuliser .......................................................................... 29
Connection tubing ............................................................ 37
Visual inspection and storage .......................................... 38
TROUBLESHOOTING..................................................... 39
TECHNICAL DATA.......................................................... 39
General nebuliser data ..................................................... 39
Aerosol characteristics according to ISO27427 .............. 40
FURTHER INFORMATION.............................................. 41
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1 IMPORTANT INFORMATION
1.1 Intended purpose
The PARILCPLUS nebuliser generates inhalable aerosols1 for
treating the lower airways.
Together with a PARIcompressor or the PARICENTRAL and
with PARIaccessories, the nebuliser forms an inhalation sys-
tem.
The nebuliser is suitable for use in treating patients in all age
groups.
Only solutions and suspensions that are approved for use in
nebuliser treatment may be used.
The nebuliser must only be connected with a PARIcompressor
or with a central gas supply system. The PARICENTRAL is in-
tended for the connection with the central gas supply system.
This PARIproduct can be used in a home environment, as well
as in professional health institutions. When used in a home en-
vironment, this PARIproduct is intended for single-patient use
only (no patient change). In a professional environment, the
device can be used with different patients as long as the cor-
responding hygiene reprocessing measures are complied with.
This product must be used only by individuals who understand
the contents of the instructions for use and are able to use the
product safely. Individuals in the following groups must be su-
pervised by a person who is responsible for their safety:
– Babies, infants, and children
– Individuals with limited capabilities (e.g. physical, mental,
sensory)
If the patient is not able to use this product safely on their own,
then the treatment must be carried out by the responsible per-
son.
This PARIproduct is suitable only for patients who are able to
breathe by themselves and are conscious.
1) Aerosol: Small particles of solid, liquid, or mixed composition (fine “mist”)
suspended in gases or air.
– 5 –

An application takes approximately5to 10minutes (depending
on the quantity of fluid), but in any case no more than
20minutes.
The frequency and duration of use is determined by profes-
sional medical staff2 according to the individual needs of the
patient.
1.2 Indication
For treatment of diseases of the lower airways.
1.3 Contraindication
There are no contraindications known to PARIGmbH.
2) Professional medical staff: Doctors, pharmacists, and physiotherapists.
– 6 –

1.4 Labelling
The following symbols can be found on the product and/or the
packaging:
Medical device
Legal manufacturer
Date of manufacture
Item no.
Production batch number, lot number
Unique Device Identifier (UDI)
This product conforms to the EU Medical Device
Regulation2017/745.
Follow the instructions for use
Mouthpiece with exhalation valve
Inhalation valve
Connection tubing
Nebuliser insert
PARI LC PLUS nebuliser
LC interrupter
Air filter for compressor types128/130/152
Air filterfor compressor type 041
Air filter for compressor types028/085
Tubing adapter
Filter changer
– 7 –

1.5 Safety and warning 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 be used only 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.
Labelling and classification of warning
instructions
In these instructions for use, safety-critical warnings are cat-
egorised according to the following hazard levels:
DANGER
DANGER indicates a hazardous situation which will lead to
very severe injuries or death if it is not avoided.
WARNING
WARNING indicates a hazardous situation which can lead to
very 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 hazardous situation which can lead to ma-
terial damage if it is not avoided.
– 8 –

General
If non-approved solutions or suspensions are used for
nebulisation, then nebuliser aerosol characteristics may differ
from the information provided by the manufacturer.
This product is not suitable for use in an anaesthetic breathing
system or a ventilator breathing system.
Tracheotomised patients cannot inhale using a mouthpiece. To
perform inhalation therapy, they require specific equipment. In
this case, please contact your doctor for further information.
Skin care products containing oils or fats can damage the soft
plastic components. The patient should refrain from using skin
care products of this kind while using the device.
If your health condition does not improve or it even wor-
sens as a result of the treatment, seek professional med-
ical advice.
Treatment of babies, infants, and anyone who
requires assistance
DANGER
Life-threatening situation from strangulation
Individuals who are not able to perform the therapy session
without assistance or who cannot appreciate the hazards are
at increased risk of injury through strangulation with the
power cord or connection tubing. Such individuals include
babies, children, and people with limited capabilities, for ex-
ample.
• Ensure that for these individuals a person responsible for
their safety either supervises or performs the application.
– 9 –

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 out
of the reach of babies and infants at all times.
Hygiene
Comply with the following hygiene instructions:
– Use only components that have been thoroughly cleaned
and dried. Contamination and residual moisture encourage
bacterial growth, which increases the risk of infection.
– Before every use and reprocessing cycle, wash your hands
thoroughly.
– Make absolutely sure you also carry out reprocessing before
using the device for the first time.
– Always use drinking water for reprocessing.
– Make sure all components are dried properly after each re-
processing step.
– Do not keep the components in a damp environment or to-
gether with damp objects.
Reporting serious incidents
Report serious adverse incidents to the manufacturer and to
the competent authority.
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2 PRODUCT DESCRIPTION
2.1 Components
Please refer to the package for information on the supplied
components.
2.2 Overview and product designations
1
1e
1c 1b 1a
1f
1d
2
(1) Nebuliser
(1a) Inhalation valve
(1b) Nozzle attachment
(1c) Nebuliser lower part
(1d) LCinterrupter
(1e) Mouthpiece
(1f) Connection tubing
(2) Air filter for compressor
2.3 Product variants
PARILCPLUS (nozzle insert: transparent)
With mouthpiece for treatment of the airways in adults and chil-
dren aged approx. 4years and older.
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2.4 Product combinations
The PARInebuliser can be connected to all PARIcompressors
or to a central medical gas supply system via a
PARICENTRAL.
The nebuliser can be used in combination with a range of PARI
accessories.
2.5 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 with which it is
filled, for example the medication.
This aerosol is breathed into the
lungs through the mouthpiece or
optionally a mask.
The LCinterrupter makes it possible to interrupt aerosol gener-
ation while the patient breathes out, thereby optimising medica-
tion use.
– 12 –

2.6 Material information
The individual components are made from the following materi-
als:
Product
component Material
Inhalation valve Polypropylene, silicone
Nozzle attachment Polypropylene
Nebuliser lower part Polypropylene
LCinterrupter Polypropylene
Mouthpiece (with
exhalation valve)
Polypropylene, thermoplastic elastomer
Connection tubing Polyvinyl chloride
Tubing connector Thermoplastic elastomer
2.7 Service life
The individual product components have the following expec-
ted lifetimes:
Product component Service life
Nebuliser, connection tubing
and accessories
in a home environment
[see:REPROCESSING IN A
HOME ENVIRONMENT,
page22]
Nebuliser, connection tubing
and accessories
in a professional environment
[see:REPROCESSING IN
PROFESSIONAL HEALTH
INSTITUTIONS, page28]
When the expected operating life has been reached, replace
the affected component. For this, nebuliser replacement sets (a
nebuliser with connection tubing) or PARIYearPacks (a
nebuliser with connection tubing and an air filter for a com-
pressor) are available.
– 13 –

3 USE
All the steps described below must be carried out correctly.
If the nebuliser is to be connected to a central gas supply sys-
tem via a PARICENTRAL, 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, deformed or seriously discoloured
parts.
• Follow the assembly instructions in these instructions for
use.
• Insert the nozzle insert into the
nebuliser lower part.
• 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.
– 15 –

Using accessories
Information on assembling accessories is included in the in-
structions for use of the respective accessory3.
Filling the nebuliser
• Insert the nebuliser in the holder on the compressor in-
tended for this purpose.
• If applicable, detach the inhalation valve from the nebuliser.
• From above, pour the required
quantity of inhalation solution
into the nebuliser.
Be sure to follow the instruc-
tions regarding the minimum
and maximum fill volumes
[see:General nebuliser data,
page39]. If the nebuliser con-
tains too little or too much li-
quid, the nebulisation and con-
sequently the therapy will be
less effective.
• Push the inhalation valve onto
the nebuliser.
3) Instructions for use of accessories are included with the respective
accessory. They can also be ordered from the manufacturer or distributor.
– 16 –

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 de-
scribed.
– 17 –

3.2 Performing treatment
All the safety instructions and warnings in these instruc-
tions for use must have been read and understood before
any treatment is carried out.
Always hold the nebuliser upright during treatment.
• If necessary, use the tubing
adapter to connect the connec-
tion tubing and the com-
pressor.
•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 infu-
sions), check carefully to en-
sure that the connection tubing
correctly connects the com-
pressor to the nebuliser. Otherwise, there is a danger that
different connection options may be mixed-up with each
other.
• Insert the connection tubing of the nebuliser with a slight
twist into the air connection on the compressor.
– 18 –

• Take the nebuliser out of its
holder on the compressor, and
hold it upright.
• Verify that all parts are firmly
connected to each other.
•DANGER!Life-threaten-
ing situation from electrocu-
tion if there is a device fault!
Switch the compressor off im-
mediately, and disconnect the
power plug from the mains
socket if a fault is suspected
(e.g. if the device is dropped,
or there is a smell of burning
plastic). If there is a device
fault, there may be a risk of contact with live parts. This in
turn may lead to an electric shock.
Switch the compressor on by shifting the on/off switch to
"ON”.
• Ensure that an aerosol is being generated (a fine mist is es-
caping from the nebuliser) before you begin the treatment.
– 19 –

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.
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).
– 20 –