Pari SINUS2 User manual

Instructions for use
PARISINUS2 nebuliser system
PARISINUS2 compressor (Type 128)
PARILCSPRINT®SINUS nebuliser (Type023)
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SINUS2 nebuliser
systems in the following countries:
Countries outside the EU
Version of these instructions for use: VersionF – 2020-02,
Approved version dated2019-11-21
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
The product is compliant with the requirements according to:
– 93/42/EEC (Medical devices)
– 2011/65/EU (RoHS)
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®,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
questions 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 .............................................. 12
Components ..................................................................... 12
Working parts ................................................................... 13
Description of function...................................................... 14
Material information.......................................................... 15
Maintenance..................................................................... 15
Operating life .................................................................... 15
APPLICATION ................................................................. 16
Setting up the compressor ............................................... 16
Preparing for treatment .................................................... 18
Performing treatment........................................................ 21
Ending the treatment ........................................................ 24
REPROCESSING ............................................................ 25
Single patient use............................................................. 25
Multiple patient use .......................................................... 29
Care of the PARISINUStubingsystem ........................... 30
Replacing the air filter....................................................... 30
Inspecting ......................................................................... 31
Storage............................................................................. 31
TROUBLESHOOTING..................................................... 32
TECHNICAL DATA.......................................................... 33
Compressor...................................................................... 33
Nebuliser .......................................................................... 35
– 5 –

MISCELLANEOUS .......................................................... 36
Disposal............................................................................ 36
Links ................................................................................. 37
Labelling ........................................................................... 37
APPENDIX: Reprocessing in professional environ-
ments (for only one patient) .......................................... 39
Compressor...................................................................... 39
Nebuliser .......................................................................... 39
PARISINUStubingsystem.............................................. 41
– 6 –

1 IMPORTANT INFORMATION
1.1 Intended purpose
The PARISINUS2 nebuliser system consists of a PARISI-
NUS2 compressor and a PARILCSPRINTSINUS nebuliser.
The system is used for treatment of the upper airways.
The nebuliser system must only be used by individuals who un-
derstand the contents of the instructions for use and are able to
operate the nebuliser system safely. Individuals in the following
groups must be supervised by a person who is responsible for
their safety:
– Children
– Individuals with limited capabilities (e.g., physical, mental,
sensory)
If the patient is not able to operate the nebuliser system safely
himself, the therapy must be carried out by the responsible
person.
Compressor
The purpose of the PARI compressor is to generate com-
pressed air for operating a PARInebuliser.
The PARI compressor is intended for use with multiple pa-
tients. It must only be used for PARInebulisers. The com-
pressor can be operated by the patient himself and must only
be used indoors.
Nebuliser
The PARILCSPRINTSINUS nebuliser generates aerosols1
for respiratory therapy.
For reasons of hygiene, this PARIproduct must only be used in
a home environment by a single patient. It is designed to treat
patients from age 6 up to adult.
Only solutions and suspensions that are approved for use in
nebuliser therapy may be used.
1) Aerosol: Small particles of solid, liquid or mixed composition (fine "mist")
suspended in gases or air.
– 7 –

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.
1.2 Indication
Diseases of the nose and paranasal sinuses.
1.3 Contraindications
This product is only designed for patients who are able to
breathe by themselves and are conscious.
Following surgery or where inflammation of the middle ear is
present, a risk/benefit assessment for vibrating aerosols must
be carried out by the doctor before the start of treatment.
1.4 Safety instructions
The present instructions for use contain important
information, safety instructions and precautionary
measures. The user must follow these in order to
guarantee safe operation 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 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.
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 –

Danger of electrocution
The compressor is an electrical device that is powered by sup-
ply voltage. It has been designed so that no live parts are ac-
cessible. However, if ambient conditions are unfavourable or if
the compressor or power cord is damaged, this protection may
no longer be provided. It may then be possible to come into
contact with live parts. This in turn may lead to an electric
shock. To avoid this danger, follow the instructions below:
– Make sure that the compressor housing, the power cord and
the power plug are undamaged every time before use. The
compressor must not be operated
– if the housing, the power cord or the power plug is
damaged,
– if a fault is suspected following a fall or similar.
– Never leave the compressor unattended while it is in use.
– Plug the compressor into an easily accessible socket. It
should be possible to unplug the power plug at all times.
– Switch the compressor off and disconnect the power plug
from the mains socket immediately:
– if it is suspected that the compressor or the power cord
might have been damaged (e.g., after the compressor
has fallen or if there is a smell of burning plastic)
– if a malfunction occurs during operation
– before cleaning and maintaining the device
– immediately after use
– Keep the power cord away from domestic animals (e.g., ro-
dents). They may damage the insulation on the power cord.
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.
– 9 –

Danger of a device defect
Comply with the following instructions to avoid a device defect:
– Make sure that the local supply voltage matches the voltage
data marked on the compressor identification label.
– To avoid overheating of the compressor,
– Never operate the compressor while it is in a bag,
– Never cover the compressor while it is operating,
– Make sure that the ventilation slits on the compressor are
unobstructed at all times while it is operating.
– Always pull the power cord by the power plug, not the cable,
to disconnect it from the socket.
– Make sure that the power cord is never kinked, pinched or
jammed. Do not pull the power cord over sharp edges.
– Keep the compressor and the power cord away from hot
surfaces (e.g., stove top, electric fire, open fire). Direct heat
may damage the compressor housing or the insulation on
the power cord.
Impairment of treatment due to electromagnetic
interference
Use only original spare parts and original accessories from
PARI. The use of third party products can result in increased
emissions of electromagnetic interference or reduced resis-
tance of the PARIcompressor.
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.
– 10 –

– 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 children 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 a
tube). Such individuals include for example babies, children
and people with limited capabilities. For these individuals, a
person responsible for safety must supervise or carry out the
application.
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.
– 11 –

2 PRODUCT DESCRIPTION
2.1 Components
The following components are included in the package (these
may differ from the picture on the packaging):
1 2a
2h
2b 2d
2c 2e 2f 2g
(1) Compressor
(2) PARILCSPRINTSINUS nebuliser
(2a) Nebuliser upper part
(2b) Nozzle insert (orange)
(2c) Nebuliser lower part
(2d) Adapter for vibration
(2e) Nasal plug
(2f) Nasal joining piece
(2g) Bend
(2h) PARISINUStubingsystem
– 12 –

2.2 Working parts
The compressor includes the following working parts:
9 567 4
2
3
3
1
3
8
2a
(1) Carrying handle
(2) Power cord3 (connected inseparably to the compressor)
(2a) Cable holder
(3) Ventilation slits
(4) Holder for nebuliser
(5) Identification label (bottom of device)
(6) Air connection
(7) Air filter
(8) Vibration connection
(9) On/off switch
3) The power plug type is country-specific. The figure shows the europlug
(type"C").
– 13 –

2.3 Description of function
Compressed air
Aerosol
(pulsating)
Air inflow
(pulsating)
The compressor supplies the nebuliser with compressed air.
Compressed air
Aerosol
(pulsating)
Air inflow
(pulsating)
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 delivered to
the nose and paranasal sinuses
through the nasal insert. The
pulsation supports this process.
– 14 –

2.4 Material information
The individual product components are made from the follow-
ing materials:
Product component Material
Nebuliser upper part Polypropylene, thermoplastic elastomer
Nozzle insert Polypropylene
Nebuliser lower part Polypropylene, thermoplastic elastomer
PARISINUStubing
system
Polyvinyl chloride
Tubing endpiece Thermoplastic elastomer
Nasal joining piece Polypropylene, thermoplastic elastomer
Adapter for vibration Thermoplastic elastomer
Nasal plug Silicone
Bend Polypropylene
2.5 Maintenance
The compressor is maintenance free.
2.6 Operating life
The individual product components have the following expec-
ted lifetimes:
Product component Operating life
Compressor Approx.1,000operating hours (this
corresponds to max. 5years)
If the compressor is still in use after
this time, have the compressor
tested. To do this, contact the
manufacturer or distributor.
Nebuliser (all components
except the PARISINUS
tubing system)
300disinfections, max.1year
PARISINUStubingsystem Max. 1year
– 15 –

3 APPLICATION
People who assist others in carrying out the therapy must en-
sure that all of the steps described below are carried out
correctly.
3.1 Setting up the compressor
The room in which the compressor is operated must satisfy
certain requirements [see:During operation, page34]. Fur-
thermore, please note the following warnings before setting the
compressor up:
WARNING
Risk of fire due to a short circuit
A short circuit in the compressor can cause a fire. In order to
reduce the risk of fire in such an event, follow the instructions
below:
• Do not operate the compressor close to readily flammable
objects such as curtains, tablecloths, or paper.
• Do not operate the compressor in areas where there is a
risk of explosion or in the presence of oxidising gases
(e.g., oxygen, nitrous oxide, flammable anaesthetics).
CAUTION
Quality of treatment impaired by electromagnetic
interference
Electrical devices can cause electromagnetic interference.
Interference can impair the function of the devices and thus
also the effectiveness of the treatment.
• Do not place the PARIdevice immediately beside or on
top of other devices.
• Keep at a minimum distance of 30cm from portable wire-
less communication devices (including accessories there-
for, such as antenna cables or external antennas).
• If the PARIdevice has to be placed immediately beside or
on top of other devices for operation, all devices must be
monitored to ensure that they are working properly.
– 16 –

CAUTION
Danger of injury from falling compressor
A compressor placed in a poor position poses a risk of injury.
• Do not place the compressor above head height.
• Make sure that the compressor cannot be pulled down by
the power cord or the connection tubes.
• Do not place the compressor on a soft surface such as a
sofa, a bed or a tablecloth.
NOTE
Danger of device fault caused by dust
If the compressor is operated in a very dusty atmosphere,
more dust may collect inside the housing. This may cause a
fault in the device.
• Do not operate the compressor on the floor, under the bed
or in workshops.
• Only operate the compressor in a low-dust environment.
Set the compressor up as follows:
• Place the compressor on a firm, flat, dust-free, dry surface.
• Plug the power plug into a suitable socket.
CAUTION!Route the power cord in such a way that it is
not a tripping hazard and no one can become entangled in
it. Poorly routed cable connections pose a risk of injury.
– 17 –

3.2 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.
• Press the nozzle insert lightly
onto the nozzle in the nebuliser
lower part.
The arrow on the nozzle insert
must point upwards.
• Place the nebuliser upper part
on the nebuliser lower part and
turn it clockwise to lock the two
parts together.
• Connect the nasal joining
piece to the bend and then
connect both to the nebuliser.
– 18 –

• Insert one tubing connector on
the PARISINUS tubing system
in the bottom of the nebuliser.
Filling the nebuliser
NOTE
Nebuliser lid might break off
If the lid is twisted in the wrong direction, it may break off.
The nebuliser will then be unusable and irreparable.
• Never move the lid except in the direction allowed by the
hinge.
• Insert the nebuliser in the holder on the compressor in-
tended for this purpose.
• Open the nebuliser lid by pressing your thumb against the
underside of the lid.
• 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35]. If the nebuliser
contains too little or too much
liquid, the nebulisation and
consequently the therapy will
be less effective.
• Close the nebuliser lid.
Make sure that the lid snaps into place.
– 19 –

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.
Connecting the tubes
The PARISINUS tubing system consists of two identical tubes.
One tube is needed for the compressed air supply, the other
helps to generate the vibration.
To connect the tubing system up fully, proceed as follows:
• Insert the corresponding con-
nector of the unconnected tube
in the vibration adapter.
• Insert the adapter in the
nebuliser upper section.
• Insert the free tubing connect-
ors in the corresponding con-
nectors on the compressor.
Info: The tubing connectors
can be inserted more easily if
they are twisted slightly when
inserting.
– 20 –