Pari PEP S User manual

Instructions for use
PARIPEP®SSystem
Model: PARIPEPS System (Type 018)
PEP therapy system
PARIinhalation system accessories for combination therapy
en

Read the instructions for use
Read these instructions carefully before using the product. Fol-
low all instructions and safety directions. Keep the instructions
in a safe place.
Validity of instructions for use
PARIPEPSSystem (Type018)
Contact
Email: [email protected]
Tel.: +49(0)8151-279220 (international)
[phone]279 (German)
Copyright
©2021 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®,LC SPRINT®,LCPLUS®,LCSTAR®,PARI®,PEP®
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TABLE OF CONTENTS
IMPORTANT INFORMATION.......................................... 5
Intended purpose ............................................................. 5
Indication .......................................................................... 5
Contraindication ............................................................... 6
Labelling ........................................................................... 6
Safety and warning instructions ....................................... 7
PRODUCT DESCRIPTION .............................................. 10
Components ..................................................................... 10
Overview and designations .............................................. 10
Product combinations....................................................... 11
Description of function...................................................... 11
Material information.......................................................... 12
Calibration ........................................................................ 13
Operating life .................................................................... 13
USE .................................................................................. 14
Preparing for treatment .................................................... 14
Performing treatment........................................................ 16
REPROCESSING IN HOME ENVIRONMENTS .............. 19
Reprocessing cycles ........................................................ 19
Processing limits .............................................................. 19
Preparation....................................................................... 20
Cleaning ........................................................................... 20
Disinfecting....................................................................... 22
Care of the pressure gauge and connection tubing ......... 24
Inspecting ......................................................................... 24
Drying ............................................................................... 24
Storage............................................................................. 24
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REPROCESSING IN PROFESSIONAL HEALTH INSTI-
TUTIONS.......................................................................... 25
Reprocessing cycles ........................................................ 25
Processing limits .............................................................. 25
PARI PEP S System ........................................................ 26
Connection tubing ............................................................ 33
Visual inspection and storage .......................................... 33
FURTHER INFORMATION.............................................. 34
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1 IMPORTANT INFORMATION
1.1 Intended purpose
The PARIPEPSSystem is used to mobilise secretion in acute
and chronic diseases of the lower airways (PEP therapy1). It is
used together with a PARInebuliser in combination treat-
ment (inhalation therapy and PEPtherapy at the same time).
The PARIPEPSsystem can also be used without an inhala-
tion system (PEP therapy only).
The PARIPEPSsystem can be used:
– by children from about 4 to 10years of age under the super-
vision and direction of a competent person
– by children aged 10 and older and adults after informed in-
struction
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.
The frequency and duration of use is determined by profes-
sional medical staff2 according to the individual needs of the
patient.
1.2 Indication
Diseases of the lower airways which are associated with in-
creased mucus build up.
1) PEP=Positive Expiratory Pressure
2) Professional medical staff: Doctors, pharmacists, and physiotherapists.
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1.3 Contraindication
The PARIPEPSSystem must not be used by individuals who
are suffering from untreated pneumothorax or massive hae-
moptysis.
1.4 Labelling
The following symbols can be found on the product and/or the
packaging:
Medical device
Legal manufacturer
Date of manufacture
This product conforms to the EU Medical Device
Regulation2017/745.
Consult instructions for use
Item no.
Production batch number, lot number
Mouthpiece (without exhalation valve)
Connecting element
Inhalation valve
Adjusting ring
Nose clip
Connection tubing
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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.
When the system is used in combination therapy, the instruc-
tions for use of the nebuliser and compressor 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.
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General
The PARIPEPSsystem must not be used without first receiv-
ing instruction from a healthcare professional 2.
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
For individuals who are not able to perform the therapy ses-
sion 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 capabilit-
ies.
• Ensure that for these individuals a person responsible for
their safety either supervises or implements the applica-
tion.
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.
– 8 –

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 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 product components in a damp environ-
ment or together with damp objects.
Reporting serious incidents
Serious incidents which occur in connection with this
PARIproduct must be reported promptly to the manufacturer
and/or the distributor, as well as to the competent authority.
Any incident which has led or could lead directly or indirectly to
death or an unexpected serious worsening of the health condi-
tion of a person is to be considered serious.
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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 designations
1 2 3
4
5
6
6a
6b
6c 6d
(1) Connecting element
(2) Adjusting ring
(3) Inhalation valve
(4) Mouthpiece (without exhalation valve)
(5) Nose clip
(6) Pressure gauge 0 to 100mbar
(6a) Pressure gauge
(6b) Tubing adapter
(6c) Connection tubing
(6d) Pressure gauge connector line
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2.3 Product combinations
The PARIPEPSsystem can be used with:
– Nebulisers: PARI LCPLUS, PARILCSTAR,
PARILCSPRINT, PARILCSPRINTJunior,
PARILCSPRINTSTAR, PARILCSPRINTCOMPACT,
PARILCSPRINTSP, and PARILL
– Pressure gauge
– PARIFilter/Valve Set
The PARIPEPSSystem cannot be used with masks.
2.4 Description of function
The PARIPEPSSystem is used in PEPtherapy. It can be
used alone (PEPtherapy) or together with a nebuliser and a
compressor (combination therapy).
PEP therapy
In PEPtherapy, expiratory resistance when exhaling is in-
creased by the different sizes of the holes in the PARIPEPS
System (the smaller the hole, the greater the resistance). The
increased expiratory resistance has the effect of stabilising the
airways and stimulating mucus dissolution.
The hole size must be determined individually for each patient
by a healthcare professional 2.
Combination therapy
The PARIPEPSSystem can be used together with a
nebuliser and a compressor instead of the mouthpiece (with
exhalation valve) or a mask. In this case, PEP therapy is also
performed as the patient breathes out during the nebuliser
treatment.
– 11 –

Pressure gauge
When you exhale into the PARIPEPS System, pressure
builds up in the tubing system. The pressure gauge measures
this pressure and displays it in millibars (mbar) on the scale.
The greater the pressure, the greater the expiratory resistance.
The pressure gauge makes it possible to adjust the desired ex-
piratory resistance on the PARIPEPS System and to monitor
it during PEP therapy.
The pressure gauge is connected to the PARIPEPS System
by tubes. The pressure gauge connector line and the tubing
adapter prevent any germs from the exhaled air from getting
into the connection tubing.
2.5 Material information
The individual product components are made from the follow-
ing materials:
PARIPEPSSystem
Product
component Material
PEPSconnecting
element
Polypropylene
PEPSadjusting
ring
Polypropylene
PEPSinhalation
valve
Silicone, polypropylene
Mouthpiece (without
exhalation valve)
Polypropylene
Nose clip Polyacetal, thermoplastic elastomer
– 12 –

Pressure gauge
Product
component Material
Pressure gauge
connector line
Silicone
Tubing adapter Polyamide
Connection tubing Polyvinyl chloride
Tubing connector Thermoplastic elastomer
2.6 Calibration
The pressure gauge should be calibrated every three years.
For this, please contact PARIGmbH.
2.7 Operating life
The individual product components have the following expec-
ted lifetimes:
Product component Service life
PARIPEPS System,
connector line, tubing
adapter, connection
tubing
in home environment
[see:REPROCESSING IN HOME
ENVIRONMENTS, page19]
PARIPEPS System,
connector line, tubing
adapter, connection
tubing
in professional environment
[see:REPROCESSING IN
PROFESSIONAL HEALTH
INSTITUTIONS, page25]
Pressure gauge The pressure gauge must be disposed
of when it is no longer able to be
calibrated.
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3 USE
All the steps described below must be carried out properly.
3.1 Preparing for treatment
• Close the PEPS connecting
element securely using the
cap.
Adjusting expiratory resistance
• Push the PEPS adjusting ring
onto the PEPSconnecting
element.
• Align the adjusting ring so that
the hole with the diameter re-
commended by your doctor or
therapist is positioned over the
hole in the connecting element.
Info: The smaller the hole, the
greater the expiratory resis-
tance.
• To prevent the adjusting ring
from slipping out of position,
engage lug"y" in locking notch"x".
– 14 –

PEP therapy
• Insert the PEPSinhalation
valve in the connecting ele-
ment.
• Insert the mouthpiece (without
exhalation valve) on the other
side of the connecting element.
Info: Make sure that the blue in-
halation valve washer is seated
correctly.
Combination therapy
• Assemble the nebuliser
(without mouthpiece) as de-
scribed in the accompanying
instructions for use.
• Attach the PEPSconnecting
element to the nebuliser.
Info: The PEPSinhalation
valve and the mouthpiece with
exhalation valve are not
needed for combination therapy.
• Attach the mouthpiece (without exhalation valve) to the
connecting element.
– 15 –

Connecting the pressure gauge
• Open the cap on the PEPSconnecting element.
•CAUTION!Risk of infec-
tion due to contamination! If
the connection tubing is con-
nected directly to the
PARIPEPS System, germs
may build up in the tubing.
Since the connection tubing
cannot be disinfected, use the
pressure gauge exclusively
with the extra pressure gauge
connector line and the tubing
adapter, in order to avoid a risk of infection.
Push the pressure gauge connector line onto the pressure
gauge attachment point on the PEPS connecting element.
• Insert the corresponding end of the connection tubing in the
pressure gauge.
• Connect the connection tubing and the pressure gauge con-
nector line using the tubing adapter.
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.
Proceed as follows in order to carry out the treatment:
• Before starting the treatment, ensure that all parts are firmly
connected to each other.
• Make sure that the expiratory resistance is adjusted cor-
rectly [see:Adjusting expiratory resistance, page14].
If the breath resistance seems too high or too low to you
during the therapy session, stop the session and consult
your doctor or therapist.
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When using without a pressure gauge
• Make sure that the connecting element is closed securely by
the cap.
When using a pressure gauge
NOTE
Impaired treatment due to damaged pressure gauge
If the pressure gauge is damaged, the measurement results
displayed may be incorrect.
• If the pressure gauge has been dropped or suffered a
similar impact, contact the manufacturer or distributor.
• During the therapy session, monitor the expiratory resis-
tance displayed on the pressure gauge. If this is constantly
different from the prescribed value, the expiratory resistance
must be adjusted [see:Adjusting expiratory resistance,
page14].
PEP therapy
• Block your nose with the nose clip.
• Hold the mouthpiecebetween your teeth, close your lips
tightly around it and breathe in slowly and deeply.
• Exhale through the mouthpiece.
The exhaled air should pass through the hole in the
PEPSadjusting ring.
• Cough to clear any secretion that is loosened during the
treatment.
For reasons of hygiene, avoid coughing into the
PARIPEPS System.
• Continue the PEPtherapy session for the period recommen-
ded by your doctor or physiotherapist.
– 17 –

Combination therapy
• Block your nose with the nose clip.
• Hold the mouthpiecebetween your teeth, close your lips
tightly around it and breathe in slowly and deeply.
• Exhale through the mouthpiece.
The exhaled air should pass through the hole in the
PEPSadjusting ring.
• Cough to clear any secretion that is loosened during the
treatment.
For reasons of hygiene, avoid coughing into the
PARIPEPS System.
If the PEPtherapy is to be terminated before the end of the
nebuliser therapy, then the combination therapy can be paused
and the PARIPEPSSystem can be replaced by the mouth-
piece with exhalation valve or a mask. To do this, proceed as
follows:
• Switch the compressor off.
• Disconnect the
PARIPEPSSystem from the
nebuliser.
• Attach the mouthpiece with
exhalation valve or a mask to
the nebuliser.
• Switch the compressor on
again and resume the
nebuliser treatment.
– 18 –

4 REPROCESSING IN HOME
ENVIRONMENTS
The product components must be cleaned thoroughly immedi-
ately after each application and disinfected at least once a
week.
The connection tubing cannot be cleaned or disinfected.
Dry the connection tubing after each use [see:Care of the
pressure gauge and connection tubing, page24].
The maximum operating life of the connection tubing is 1 year.
4.1 Reprocessing cycles
PARIPEPSSystem – Clean immediately after every use
– Disinfect once per week
Cleaning and disinfection can be carried
out together with the nebuliser.
Pressure gauge Care as required [see:Care of the
pressure gauge and connection tubing,
page24].
4.2 Processing limits
PARI PEPS System,
disinfection
300processing cycles,
max.1year
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4.3 Preparation
If a pressure gauge has been used:
• Detach the pressure gauge connector line from the connect-
ing element.
• Detach the connection tubing from the pressure gauge.
• Detach the tubing adapter from the pressure gauge con-
nector line and the connection tubing.
General:
• If necessary, disconnect the PARIPEPSsystem from the
nebuliser.
• Dismantle the PARI PEP S system into its individual parts.
• Open the cap on the connecting element.
4.4 Cleaning
Precleaning
All individual parts must be precleaned immediately after use.
EQUIPMENT:
– Drinking water temperature of about 15°C
PROCEDURE:
• Rinse all parts used for 2minutes in running drinking water.
Manual cleaning
EQUIPMENT:
– Drinking water with a temperature of at least 40°C
– Standard commercial washing-up liquid3
– Receptacle with at least 3l capacity
3) Validated with Palmolive®.
– 20 –