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.
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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
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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]
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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
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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.
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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.
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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.
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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.
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