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.
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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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