Hygienic Re-Use; General - Pari TIA Gebrauchsanweisung

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Hygienic re-use

6.1 General

In order to prevent a risk to health, e.g., infection due to a contami-
nated nebuliser, it is imperative that the following hygiene regula-
tions are followed.
The PARI TIA nebuliser S is designed for multiple uses and multiple patients.
It is therefore imperative to carry out the following instructions for hygienic re-
use without fail:
- When the nebuliser is used for several patients, it must be cleaned, disin-
fected and sterilised before each change in patient.
- Proof of suitability of the nebulisers for effective cleaning, disinfection and
sterilisation has been obtained through an independent testing laboratory
using the recommended procedures stated in Chapter 6.3 "Cleaning/disin-
fection" (test documentation available for inspection on request). Using the
named alternatives remains the responsibility of the user.
- Please ensure that only adequately validated device-specific and product-
specific procedures are used for cleaning, disinfection and sterilisation,
and that the validated parameters are observed in each cycle.
- The cleaning and disinfection procedures must be recognised as effective
(e.g., in the list of tested and recognised disinfectants and procedures
issued by the Robert Koch Institute/DGHM) and already validated in all
cases.
If other procedures are used, their effectiveness must be confirmed during
validation. CE-approved chemical disinfectants may also be used, pro-
vided they satisfy the requirements for material resistance (see
Chapter 7.2 "Material resistance").
- 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 follow the instructions in Chapter 7.2 "Material resistance".
- In addition, please follow the hygiene regulations of the hospital or medical
practice.
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