Hygienic Re-Use; General - Pari PEP System I Instructions For Use Manual

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Hygienic re-use

6.1 General

In order to prevent a risk to health (e.g. an infection occurring as a
result of a contaminated PEP System) it is imperative that the follow-
ing hygiene regulations be followed.
The PARI PEP System is intended for multiple use. Please be aware that
different requirements regarding hygienic re-use apply to different fields of
application:
- At home (use by a single patient):
The PARI PEP System, and where applicable the PEP tubing adapter,
must be cleaned and disinfected after each use.
- Hospital/medical practice (possible use by more than one patient):
The PARI PEP System, and where applicable, the PEP tubing adapter,
must be cleaned, disinfected and sterilised after each use.
The cleaning, disinfection, and sterilisation procedures described in
Chapter 6.3 or 6.4 apply to all individual parts of the PARI PEP System
except the pressure gauge, the pressure gauge connection tube and the
adapter. These parts are to be wiped down with a damp cloth when
necessary.
Additional requirements concerning the necessary hygienic preparations
(hand care, handling of medications or inhalation solutions) in high-risk
groups (e.g., patients with cystic fibrosis) can be obtained from the relevant
support groups. Proof of suitability of the PARI PEP System for effective
cleaning, disinfection and sterilisation has been obtained using an
independent testing laboratory and using the recommended procedures
stated in Chapter 6.4.1 "Cleaning/disinfection" (test documentation available
for inspection on request). Using the specified alternatives remains the
responsibility of the user.
Please ensure adequate drying after each cleaning, disinfection and/or
sterilisation. Condensation or residual wetness can present an increased risk
through the growth of bacteria.
Please check the parts of your PARI PEP System regularly and replace any
defective (broken, misshapen, discoloured) parts.
Additionally, please read and follow the hygiene instructions in the
instructions for use of the PARI compressor and the PARI nebuliser.
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