Pari COMPACT2 User manual

Instructions for use
PARICOMPACT2 inhalation system
PARICOMPACT2 compressor (Type152)
PARILCPLUS® nebuliser (Type022)
PARIchild masksoft (Type041)
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COMPACT2
inhalation 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
downloaded 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®,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 .............................................. 13
Components ..................................................................... 13
Working parts ................................................................... 14
Description of function...................................................... 15
Material information.......................................................... 16
Maintenance..................................................................... 16
Operating life .................................................................... 16
APPLICATION ................................................................. 17
Setting up the compressor ............................................... 17
Preparing for treatment .................................................... 19
Performing treatment........................................................ 22
Ending the treatment ........................................................ 25
REPROCESSING ............................................................ 26
Single patient use............................................................. 26
Multiple patient use .......................................................... 30
Care of the connection tube ............................................. 31
Replacing the air filter....................................................... 31
Inspecting ......................................................................... 32
Storage............................................................................. 32
TROUBLESHOOTING..................................................... 33
TECHNICAL DATA.......................................................... 33
Compressor...................................................................... 33
Nebuliser .......................................................................... 36
– 5 –

MISCELLANEOUS .......................................................... 38
Disposal............................................................................ 38
Links ................................................................................. 39
Labelling ........................................................................... 39
APPENDIX: Reprocessing in professional environ-
ments for use with several patients ............................. 41
Compressor...................................................................... 41
Nebuliser and accessories ............................................... 41
Connection tubing ............................................................ 44
– 6 –

1 IMPORTANT INFORMATION
1.1 Intended purpose
The PARIinhalation system consists of a PARIcompressor, a
PARInebuliser and PARIaccessories. The system is used for
treatment of the lower airways.
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.
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 nebuliser generates aerosols1 for inhalation.
The nebuliser must only be used in a home environment and
only by a single patient for reasons of hygiene. It 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.
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.
Mask
The mask is an accessory for nebuliser treatment with a
PARInebuliser.
The PARIchild mask soft is suitable for the treatment of chil-
dren aged 4years and older2.
The mask must only be used with PARInebulisers.
For reasons of hygiene, this PARIproduct must only be used in
a home environment by a single patient.
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 inhalation solution used must
also be followed.
2) The age indicated is intended as a guidance value. Whether the mask is
actually suitable depends on the size and shape of the individual face.
– 8 –

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.3
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:
3) Professional medical staff: Doctors, pharmacists and physiotherapists.
– 9 –

– 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.,
rodents). 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.
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.
– 10 –

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

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.
– 12 –

2 PRODUCT DESCRIPTION
2.1 Components
The following components are included in the package (these
may differ from the picture on the packaging):
1 2b2c
2e
2a
2d
2
3
3a
(1) Compressor
(2) PARI LC PLUS nebuliser
(2a) Inspiratory valve
(2b) Nozzle insert (transparent)
(2c) Nebuliser lower part
(2d) Mouthpiece
(2e) Connection tubing
(3) PARIchildmasksoft
(3a) Elastic band
– 13 –

2.2 Working parts
The compressor includes the following working parts:
8 57 6 4 3
1
3
2a 2
(1) Carrying handle
(2) Power cord4 (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) On/off switch
4) The power plug type is country-specific. The figure shows the europlug
(type"C").
– 14 –

2.3 Description of function
Compressor with nebuliser
Compressed air
Aerosol
The compressor supplies the nebuliser with compressed air.
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.
Mask
The mask makes it possible to inhale aerosol through the
mouth and the nose.
The patient can breathe out through the exhalation valve at the
bottom end of the mask without having to take the mask off.
The mask can be held firmly in position on the face with the aid
of the elastic band which is attached to the side openings of
the mask.
– 15 –

2.4 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
Mouthpiece (with
exhalation valve)
Polypropylene, thermoplastic elastomer
Connection tubing Polyvinyl chloride
Tubing endpiece Thermoplastic elastomer
PARIchildmasksoft Polypropylene, thermoplastic elastomer
Elastic band Synthetic rubber
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. 500operating hours (this
corresponds to max. 3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 connection tubing)
300disinfections, max. 1year
Connection tubing max. 1year
PARIchildmasksoft 300disinfections, max. 1year
– 16 –

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.
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 Setting up the compressor
The room in which the compressor is operated must satisfy
certain requirements [see:During operation, page35]. 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).
– 17 –

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.
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 it cannot be pulled down by the power
cord or the connection tube.
• 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.
– 18 –

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.
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
before 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.
– 19 –

• Attach the connection tubing to
the nebuliser.
Using the mouthpiece
• Fit the mouthpiece onto the
nebuliser.
Using the mask
• If desired, attach the elastic
band to the mask (as shown in
the figure).
– 20 –